Device Desk

Private service · Not FDA

FDA device establishment · Naples, 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-3006783837As of September 30, 2026

STRUCTURE MEDICAL, LLC.

Registration 3006783837FEI 3009322142Naples, FL

Owner/operator: Structure Medical, 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
70
Added, last 12 months
13

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 70

CodeDeviceClassRegulationPremarket
NQOProsthesis, Spinous Process Spacer/PlateUnknownClass 3——
KTTFragment Plate SystemAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass 221 CFR 888.3030—
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedicClass 221 CFR 888.3030—
KTTA.L.P.S. ELBOW SYSTEM DISTAL HUMERAL MEDIAL PLATEAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentClass 221 CFR 888.3030—
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeOrthopedicClass 221 CFR 888.3030—
LXTInternal Joint Stabilizer - ElbowAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeClass 221 CFR 888.3030—
LXTDISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROWAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeClass 221 CFR 888.3030—
LXTA.L.P.S. ELBOW SYSTEM DISTAL HUMERAL MEDIAL PLATEAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeClass 221 CFR 888.3030—
LXTDISTAL VOLAR RADIUS PLATING SYSTEMSAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeClass 221 CFR 888.3030—
KWPSet Screw, LargeAppliance, Fixation, Spinal InterlaminalClass 221 CFR 888.3050—
KWPAppliance, Fixation, Spinal InterlaminalOrthopedicClass 221 CFR 888.3050—
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedicClass 221 CFR 888.3060—

and 58 more on your full dossier

What changed

  • Sep 15, 2026Listing added: OWI — Bone Fixation Cerclage, Sublaminar
  • Feb 1, 2026Listing added: IKN — Electromyograph, Diagnostic
  • Feb 1, 2026Listing added: PHM — Intervertebral Fusion Device With Bone Graft, Thoracic
  • Feb 1, 2026Listing added: JDS — Nail, Fixation, Bone
  • Feb 1, 2026Listing added: HAW — Neurological Stereotaxic Instrument
  • Feb 1, 2026Listing added: PDQ — Neurosurgical Nerve Locator
  • Feb 1, 2026Listing added: OLO — Orthopedic Stereotaxic Instrument
  • Feb 1, 2026Listing added: NKG — Posterior Cervical Screw System
  • Feb 1, 2026Listing added: OUR — Sacroiliac Joint Fixation
  • Jan 30, 2026Listing added: PLR — Spinal Vertebral Body Replacement Device - Cervical
  • Feb 1, 2026Listing added: KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
  • Feb 1, 2026Listing added: GWF — Stimulator, Electrical, Evoked Response
  • Feb 1, 2026Listing added: ETN — Stimulator, Nerve
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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