Device Desk

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FDA device establishment · Souderton, PA

This page shows the yearly renewal for this site, from FDA’s public record.

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Renewal dossierDD-3010032903As of September 30, 2026

FIRST ARTICLE INC

Registration 3010032903FEI 3010032903Souderton, PA

Owner/operator: First Article MFG LLC

  • Manufacture Medical Device for Another Party (Contract Manufacturer)

Renewal due by December 31, 2026

Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.

90days left in the window

The 2026 window

  1. Oct 1Window opens91 days left
  2. Nov 3Where you stand58 days left
  3. Dec 1Our pay-by date30 days left
  4. Dec 15Two weeks left16 days left
  5. Dec 23Holiday week8 days left
  6. Dec 29Two days left2 days left
  7. Dec 31Window closes0 days left
an email on that date our pay-by date to December 31
FDA fee, FY2027
$13,785
Our pay-by suggestion
Dec 1
Listed devices
130
Added, last 12 months
130

FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page

The steps, in order

  1. Pay FDA's annual feeYou

    Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.

    FDA: registration and listing payment process

  2. Wait for the payment confirmation numberYou

    FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.

    FDA: registration and listing payment process

  3. Renew the registration in FDA's systemYou

    Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.

    FDA: device registration and listing

  4. Review every listingYou

    In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.

    FDA: device registration and listing

Every listed device 130

CodeDeviceClassRegulationPremarket
KWPCREO 4.75mm Threaded CoCr Deformity Stabilization SystemAppliance, Fixation, Spinal InterlaminalAdded Apr 14, 2026Class 221 CFR 888.3050—
KWPREVERE 4.5 Stabilization SystemAppliance, Fixation, Spinal InterlaminalAdded Apr 14, 2026Class 221 CFR 888.3050—
KWPExcelsius GPSAppliance, Fixation, Spinal InterlaminalAdded Apr 14, 2026Class 221 CFR 888.3050—
KWPREVOLVEAppliance, Fixation, Spinal InterlaminalAdded Apr 14, 2026Class 221 CFR 888.3050—
KWPREVERE 6.35 Degen Ti SystemAppliance, Fixation, Spinal InterlaminalAdded Apr 14, 2026Class 221 CFR 888.3050—
KWPCREO AMP 5.5 Stabilization SystemAppliance, Fixation, Spinal InterlaminalAdded Apr 14, 2026Class 221 CFR 888.3050—
KWPELLIPSEAppliance, Fixation, Spinal InterlaminalAdded Apr 14, 2026Class 221 CFR 888.3050—
KWPQUARTEXAppliance, Fixation, Spinal InterlaminalAdded Apr 14, 2026Class 221 CFR 888.3050—
KWPREVERE 5.5 Deformity Ti SystemAppliance, Fixation, Spinal InterlaminalAdded Apr 14, 2026Class 221 CFR 888.3050—
KWPPROTEX CTAppliance, Fixation, Spinal InterlaminalAdded Apr 14, 2026Class 221 CFR 888.3050—
KWPBEACON Posted Screw SystemAppliance, Fixation, Spinal InterlaminalAdded Apr 14, 2026Class 221 CFR 888.3050—
KWPCREO ADDITIONAppliance, Fixation, Spinal InterlaminalAdded Apr 14, 2026Class 221 CFR 888.3050—

and 118 more on your full dossier

What changed

  • Apr 14, 2026Listing added: KWP — CREO 4.75mm Threaded CoCr Deformity Stabilization System
  • Apr 14, 2026Listing added: KWP — REVERE 4.5 Stabilization System
  • Apr 14, 2026Listing added: KWP — Excelsius GPS
  • Apr 14, 2026Listing added: KWP — REVOLVE
  • Apr 14, 2026Listing added: KWP — REVERE 6.35 Degen Ti System
  • Apr 14, 2026Listing added: KWP — CREO AMP 5.5 Stabilization System
  • Apr 14, 2026Listing added: KWP — ELLIPSE
  • Apr 14, 2026Listing added: KWP — QUARTEX
  • Apr 14, 2026Listing added: KWP — REVERE 5.5 Deformity Ti System
  • Apr 14, 2026Listing added: KWP — PROTEX CT
  • Apr 14, 2026Listing added: KWP — BEACON Posted Screw System
  • Apr 14, 2026Listing added: KWP — CREO ADDITION
  • Apr 14, 2026Listing added: KWP — REVERE ADDITION
  • Apr 14, 2026Listing added: KWP — SP-Fix
  • Apr 14, 2026Listing added: KWQ — REVERE ADDITION
  • Apr 14, 2026Listing added: KWQ — ASSURE
  • Apr 14, 2026Listing added: KWQ — REVLOK
  • Apr 14, 2026Listing added: KWQ — CITADEL
  • Apr 14, 2026Listing added: KWQ — BEACON Posted Screw System
  • Apr 14, 2026Listing added: KWQ — TRUSS
  • Apr 14, 2026Listing added: KWQ — REVERE 6.35 Degen Ti System
  • Apr 14, 2026Listing added: KWQ — ASSURE-X
  • Apr 14, 2026Listing added: KWQ — UNIFY
  • Apr 14, 2026Listing added: KWQ — CREO ADDITION
  • Apr 14, 2026Listing added: KWQ — PROVIDENCE
  • Apr 14, 2026Listing added: KWQ — REVERE 5.5 Deformity Ti System
  • Apr 14, 2026Listing added: KWQ — CREO 4.75mm Threaded CoCr Deformity Stabilization System
  • Apr 14, 2026Listing added: KWQ — COALITION MIS
  • Apr 14, 2026Listing added: KWQ — PIVOT MIS System
  • Apr 14, 2026Listing added: KWQ — REVERE 4.5 Stabilization System
  • Apr 14, 2026Listing added: KWQ — CREO DLX Deformity Stabilization System
  • Apr 14, 2026Listing added: HRX — CROSSWAY
  • Apr 14, 2026Listing added: PML — CREO DLX Deformity Stabilization System
  • Apr 14, 2026Listing added: OWI — SILC Fixation System
  • Apr 14, 2026Listing added: DSI — REVERE 5.5 Deformity Ti System
  • Apr 14, 2026Listing added: ODP — PRESERVE ACDF System
  • Apr 14, 2026Listing added: ODP — COALITION MIS
  • Apr 14, 2026Listing added: ODP — COLONIAL
  • Apr 14, 2026Listing added: MAX — PRESERVE ACDF System
  • Apr 14, 2026Listing added: MAX — RISE
  • Apr 14, 2026Listing added: MAX — COLONIAL
  • Apr 14, 2026Listing added: MAX — MAGNIFY
  • Apr 14, 2026Listing added: MAX — TRANSCONTINENTAL
  • Apr 14, 2026Listing added: MAX — SIGNATURE
  • Apr 14, 2026Listing added: MAX — CONTINENTAL
  • Apr 14, 2026Listing added: MAX — ELSA
  • Apr 14, 2026Listing added: MAX — LATIS
  • Apr 14, 2026Listing added: MAX — INDEPENDENCE
  • Apr 14, 2026Listing added: MAX — CALIBER
  • Apr 14, 2026Listing added: MAX — InterContinental
  • Apr 14, 2026Listing added: PHM — CONTINENTAL
  • Apr 14, 2026Listing added: PHM — TRANSCONTINENTAL
  • Apr 14, 2026Listing added: OVE — COLONIAL
  • Apr 14, 2026Listing added: OVE — COALITION
  • Apr 14, 2026Listing added: OVE — COALITION MIS
  • Apr 14, 2026Listing added: OVD — COLONIAL
  • Apr 14, 2026Listing added: OVD — ELSA
  • Apr 14, 2026Listing added: OVD — RISE
  • Apr 14, 2026Listing added: OVD — INDEPENDENCE
  • Apr 14, 2026Listing added: OVD — MAGNIFY
  • Apr 14, 2026Listing added: OVD — InterContinental
  • Apr 14, 2026Listing added: OVD — CONTINENTAL
  • Apr 14, 2026Listing added: MWI — REVERE 5.5 Deformity Ti System
  • Apr 14, 2026Listing added: HAW — Excelsius GPS
  • Apr 14, 2026Listing added: OLO — SI-LOK Select
  • Apr 14, 2026Listing added: OLO — CREO AMP 5.5 Stabilization System
  • Apr 14, 2026Listing added: OLO — QUARTEX
  • Apr 14, 2026Listing added: OLO — Excelsius GPS
  • Apr 14, 2026Listing added: OLO — ELLIPSE
  • Apr 14, 2026Listing added: OLO — Guided Instruments
  • Apr 14, 2026Listing added: MNI — BEACON Posted Screw System
  • Apr 14, 2026Listing added: MNI — REVERE ADDITION
  • Apr 14, 2026Listing added: MNI — PIVOT MIS System
  • Apr 14, 2026Listing added: MNI — REVERE 5.5 Degen Ti System
  • Apr 14, 2026Listing added: MNI — REVERE 5.5 Deformity Ti System
  • Apr 14, 2026Listing added: MNI — REVERE 6.35 Degen Ti System
  • Apr 14, 2026Listing added: MNI — CREO 4.75mm Threaded CoCr Deformity Stabilization System
  • Apr 14, 2026Listing added: MNI — PROTEX CT
  • Apr 14, 2026Listing added: MNI — REVERE 4.5 Stabilization System
  • Apr 14, 2026Listing added: MNI — REVLOK
  • Apr 14, 2026Listing added: MNI — REVOLVE
  • Apr 14, 2026Listing added: NQW — RELIEVE
  • Apr 14, 2026Listing added: NQW — HAVEN
  • Apr 14, 2026Listing added: MNH — PIVOT MIS System
  • Apr 14, 2026Listing added: MNH — REVOLVE
  • Apr 14, 2026Listing added: MNH — REVERE 5.5 Degen Ti System
  • Apr 14, 2026Listing added: MNH — BEACON Posted Screw System
  • Apr 14, 2026Listing added: MNH — REVERE ADDITION
  • Apr 14, 2026Listing added: MNH — REVERE 4.5 Stabilization System
  • Apr 14, 2026Listing added: MNH — REVERE 5.5 Deformity Ti System
  • Apr 14, 2026Listing added: MNH — REVLOK
  • Apr 14, 2026Listing added: MNH — REVERE 6.35 Degen Ti System
  • Apr 14, 2026Listing added: MNH — CREO 4.75mm Threaded CoCr Deformity Stabilization System
  • Apr 14, 2026Listing added: OSH — CREO 4.75mm Threaded CoCr Deformity Stabilization System
  • Apr 14, 2026Listing added: OSH — REVERE 4.5 Stabilization System
  • Apr 14, 2026Listing added: OSH — REVERE 6.35 Degen Ti System
  • Apr 14, 2026Listing added: HRS — ANTHEM Ti Proximal Humerus Fracture System
  • Apr 14, 2026Listing added: NKG — QUARTEX
  • Apr 14, 2026Listing added: NQP — TRANSITION
  • Apr 14, 2026Listing added: KWI — PIVOT MIS System
  • Apr 14, 2026Listing added: OUR — SI-LOK Select
  • Apr 14, 2026Listing added: OUR — SI-LOK
  • Apr 14, 2026Listing added: HWC — SI-LOK
  • Apr 14, 2026Listing added: HWC — CORRIDOR
  • Apr 14, 2026Listing added: HWC — ANTHEM Ti Proximal Humerus Fracture System
  • Apr 14, 2026Listing added: MQP — COLOSSEUM
  • Apr 14, 2026Listing added: MQP — PRESERVE ACDF System
  • Apr 14, 2026Listing added: MQP — XPand
  • Apr 14, 2026Listing added: MQP — COLONIAL
  • Apr 14, 2026Listing added: MQP — FORTIFY - Large
  • Apr 14, 2026Listing added: PLR — COLOSSEUM
  • Apr 14, 2026Listing added: PLR — FORTIFY - Large
  • Apr 14, 2026Listing added: PEK — SP-Fix
  • Apr 14, 2026Listing added: PEK — AERIAL
  • Apr 14, 2026Listing added: FIP — REVERE 5.5 Deformity Ti System
  • Apr 14, 2026Listing added: NKB — REVERE 5.5 Degen Ti System
  • Apr 14, 2026Listing added: NKB — REVLOK
  • Apr 14, 2026Listing added: NKB — CREO AMP 5.5 Stabilization System
  • Apr 14, 2026Listing added: NKB — CREO 4.75mm Threaded CoCr Deformity Stabilization System
  • Apr 14, 2026Listing added: NKB — Excelsius GPS
  • Apr 14, 2026Listing added: NKB — CREO ADDITION
  • Apr 14, 2026Listing added: NKB — REVERE 5.5 Deformity Ti System
  • Apr 14, 2026Listing added: NKB — REVERE 6.35 Degen Ti System
  • Apr 14, 2026Listing added: NKB — PIVOT MIS System
  • Apr 14, 2026Listing added: NKB — CREO DLX Deformity Stabilization System
  • Apr 14, 2026Listing added: NKB — REVOLVE
  • Apr 14, 2026Listing added: NKB — REVERE ADDITION
  • Apr 14, 2026Listing added: NKB — BEACON Posted Screw System
  • Apr 14, 2026Listing added: NKB — REVERE 4.5 Stabilization System
  • Apr 14, 2026Listing added: MRW — CORRIDOR
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov). FDA does not endorse Device Desk.FDA’s own record is always the authority.

How we got this date

  1. FDA asks every device site to renew its registration each year.
  2. The renewal window runs from October 1, 2026 to December 31, 2026.
  3. A renewal in this window covers 2027.
  4. The rule is 21 CFR 807.22(b).

FDA’s record shows this registration runs through 2026.

We read this from FDA’s public record on September 30, 2026.

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