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Silex Sacroiliac Joint Fusion System X079-0063

by Xtant Medical Holdings, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 NumberM697X07900631 UDI-DI Date31 Aug 2015ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Silex Sacroiliac Joint Fusion System
Generic Name
Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Model / Reference
X079-0063
Primary DI / UDI-DI
M697X07900631
FDA Product Code
HTW
GMDN Term
Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Device Class
Class I
Regulation Number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 12.5 Millimeter

Related devices

Category: Sacroiliac joint transarticular fixation/arthrodesis implantation kit

Other devices from Xtant Medical Holdings, Inc.

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Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

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