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Onyx iGPS Awl Tip Tap 6.5mm 503189-0650

by Si-Bone Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810055526307 UDI-DI Date30 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Onyx iGPS Awl Tip Tap 6.5mm
Generic Name
Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Model / Reference
503189-0650
Primary DI / UDI-DI
00810055526307
510(k) Number
FDA Product Code
OLO
GMDN Term
Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Device Class
Class II
Regulation Number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional

Related devices

Cleared under the same submission (K262067)

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Other devices from Si-Bone Inc.

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Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No