Device Desk

Private service · Not FDA

FDA device establishment · Boca Raton, 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-3012495575As of September 30, 2026

SURGENTEC LLC

Registration 3012495575FEI 3012495575Boca Raton, FL

Owner/operator: SurGenTec LLC

  • Manufacture 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
46
Added, last 12 months
11

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 46

CodeDeviceClassRegulationPremarket
KWPBacfuse 8 & 10mmAppliance, Fixation, Spinal InterlaminalClass 221 CFR 888.3050K101525
KWPBacfuse Line ExtensionAppliance, Fixation, Spinal InterlaminalClass 221 CFR 888.3050K110367
HRXDecompression Kit with Direct Cannula Access and VisualizationArthroscopeAdded Jul 8, 2026Class 221 CFR 888.1100K252546
MQVOsteoFlo Fiber GraftFiller, Bone Void, Calcium CompoundClass 221 CFR 888.3045K251720
MQVOsteoFlo HydroFiberFiller, Bone Void, Calcium CompoundClass 221 CFR 888.3045K243949
MQVOsteoFlo HydroFiberFiller, Bone Void, Calcium CompoundClass 221 CFR 888.3045K242797
MQVFiller, Bone Void, Calcium CompoundOrthopedicClass 221 CFR 888.3045K231716
MQVOsteoFloFiller, Bone Void, Calcium CompoundClass 221 CFR 888.3045K200064
KNWALARA BMA Neuro AccessInstrument, BiopsyClass 221 CFR 876.1075K243945
KNWALARA BMA Neuro Access KitInstrument, BiopsyClass 221 CFR 876.1075K240664
PDQALARA Neuro Access KitNeurosurgical Nerve LocatorClass 221 CFR 874.1820K190163
PDQALARA BMA Neuro Access KitNeurosurgical Nerve LocatorClass 221 CFR 874.1820K240664

and 34 more on your full dossier

What changed

  • Jul 8, 2026Listing added: HRX — Decompression Kit with Direct Cannula Access and Visualization (K252546)
  • May 13, 2026Listing added: OLO — TiLink- L Navigation (K253604)
  • Jun 23, 2026Listing added: OLO — ION-C Navigation (K260329)
  • Aug 27, 2026Listing added: OLO — Tilink-L Helix (K261381)
  • Jul 28, 2026Listing added: OLO — ION-L Navigated Instruments (K262121)
  • Jul 8, 2026Listing added: HAE — Decompression Kit with Direct Cannula Access and Visualization (K252546)
  • Aug 27, 2026Listing added: OUR — Tilink-L Helix (K261381)
  • Mar 30, 2026Listing added: OUR — TiLink InSite (K242414)
  • Aug 27, 2026Listing added: FMF — Assorted Adapter Tips (K262581)
  • Jan 26, 2026Listing added: MRW — ION 3D Cervical Disposable Kit (K251714)
  • Jun 23, 2026Listing added: MRW — ION-L (K261209)
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

Watch for mail that looks like it is from FDA and asks you to pay a company. You pay FDA’s fee only in FDA’s own system.

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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