Device Desk

Private service · Not FDA

FDA device establishment · Palm Coast, FL

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

Device Desk is a private service. We are not FDA. We never file or pay for you.

Renewal dossierDD-3015946784As of September 30, 2026

ORTHONOVIS, INC.

Registration 3015946784FEI 3015946784Palm Coast, FL

Owner/operator: OrthoNovis, Inc.

  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

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
31
Added, last 12 months
8

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 31

CodeDeviceClassRegulationPremarket
KTTONX Large External Fixation SystemAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass 221 CFR 888.3030K213905
MQVBTB Bone Graft PuttyFiller, Bone Void, Calcium CompoundAdded Mar 25, 2026Class 221 CFR 888.3045K082672
JDSIONz IntraHeal Trochanteric Fixation SystemNail, Fixation, BoneClass 221 CFR 888.3030K203811
HTYIONz IntraHeal Trochanteric Fixation SystemPin, Fixation, SmoothClass 221 CFR 888.3040K203811
HTYOrthoNovis BPSS Cannulated ScrewsPin, Fixation, SmoothClass 221 CFR 888.3040K130613
HTYCannulated Screw and Kirschner (K wire) SystemPin, Fixation, SmoothAdded Nov 28, 2025Class 221 CFR 888.3040K252758
JDWIONz IntraHeal Trochanteric Fixation SystemPin, Fixation, ThreadedClass 221 CFR 888.3040K203811
HRSBPSS Foot Plating SystemPlate, Fixation, BoneClass 221 CFR 888.3030K162674
HRSOrthoNovis Bone Plate and Screw SystemPlate, Fixation, BoneClass 221 CFR 888.3030K130614
HRSBPS Wrist Fracture SystemPlate, Fixation, BoneAdded Nov 28, 2025Class 221 CFR 888.3030K250498
HRSBPS Bone Fragment Fixation Plates, Screws and WashersPlate, Fixation, BoneClass 221 CFR 888.3030K250055
HRSBPSS Affinity Wrist Fracture SystemPlate, Fixation, BoneClass 221 CFR 888.3030K191641

and 19 more on your full dossier

What changed

  • Mar 25, 2026Listing added: MQV — BTB Bone Graft Putty (K082672)
  • Nov 28, 2025Listing added: HTY — Cannulated Screw and Kirschner (K wire) System (K252758)
  • Nov 28, 2025Listing added: HRS — BPS Wrist Fracture System (K250498)
  • Nov 28, 2025Listing added: HWC — Cannulated Screw and Kirschner (K wire) System (K252758)
  • Nov 28, 2025Listing added: HWC — BPS Wrist Fracture System (K250498)
  • Dec 5, 2025Listing added: HTN — NoviCoid AC Joint Repair System (K153211)
  • Nov 28, 2025Listing added: HTN — Cannulated Screw and Kirschner (K wire) System (K252758)
  • Mar 25, 2026Listing added: KGN — CSM (K012990)
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.

Read FDA’s page on registration

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Keep this desk: $249 a year

We keep this page current each week. We email you before each date in the window, and when FDA’s record shows you renewed.

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Renews each year until you cancel. Cancel any time from your account.

Is this right?

We copy this from FDA’s public record. FDA’s own record always wins. A listing missing here does not prove anything about FDA’s record.

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