Device Desk

Private service · Not FDA

FDA device establishment · Santa Clara, CA

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-3021948057As of September 30, 2026

SI-BONE, INC.

Registration 3021948057FEI 3021948057Santa Clara, CA

Owner/operator: SI-BONE, Inc.

  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility
  • 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
56
Added, last 12 months
4

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 56

CodeDeviceClassRegulationPremarket
PDQSI-BONE Neuromonitoring KitNeurosurgical Nerve LocatorClass 221 CFR 874.1820K161893
OLOiFuse TORQ Implant SystemOrthopedic Stereotaxic InstrumentClass 221 CFR 882.4560K222605
OLOiFuse Bedrock Granite™ Implant SystemOrthopedic Stereotaxic InstrumentClass 221 CFR 882.4560K220195
OLOiGPS Navigation InstrumentsOrthopedic Stereotaxic InstrumentClass 221 CFR 882.4560K251780
OLOiFuse Implant System - iFuse Navigation Instrument SetOrthopedic Stereotaxic InstrumentClass 221 CFR 882.4560K203110
OLOiFuse TORQ Implant SystemOrthopedic Stereotaxic InstrumentClass 221 CFR 882.4560K222774
OLOiFuse TORQ Implant SystemOrthopedic Stereotaxic InstrumentClass 221 CFR 882.4560K231689
OLOiFuse NavigationOrthopedic Stereotaxic InstrumentClass 221 CFR 882.4560K172268
OLOiFuse TORQ Implant SystemOrthopedic Stereotaxic InstrumentClass 221 CFR 882.4560K241574
OLOiFuse TORQ TNT Implant SystemOrthopedic Stereotaxic InstrumentClass 221 CFR 882.4560K241504
OLOFIXED TRACKER SCREWDRIVEROrthopedic Stereotaxic InstrumentClass 221 CFR 882.4560K232800
OLOGranite Point Lock Set ScrewOrthopedic Stereotaxic InstrumentAdded Nov 21, 2025Class 221 CFR 882.4560K253094

and 44 more on your full dossier

What changed

  • Nov 21, 2025Listing added: OLO — Granite Point Lock Set Screw (K253094)
  • Feb 12, 2026Listing added: OUR — iFuse INTRA Ti Implant System (K253488)
  • Nov 21, 2025Listing added: OUR — Granite Point Lock Set Screw (K253094)
  • Nov 21, 2025Listing added: NKB — Granite Point Lock Set Screw (K253094)
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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