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SiNAPTIC Osteotomy Wedge System Cotton Wedge - Rev. 0

by SINTX Technologies Inc. 12 variants

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 NumberG817S111121612 UDI-DI Date5 Apr 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  • Withdrawn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
SiNAPTIC Osteotomy Wedge System
Generic Name
Metallic osteotomy fusion cage, non-customized
Model / Ref / Catalog
Cotton Wedge - Rev. 0, S-111-121612
Primary DI / UDI-DI
G817S111121612
510(k) Number
FDA Product Code
PLF
GMDN Term
Metallic osteotomy fusion cage, non-customized
Device Class
Class II
Regulation Number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization
MRI Safety
MR Safe
Size
Width — 12 Millimeter
Depth — 16 Millimeter
Height — 12 Millimeter

Related devices

Cleared under the same submission (K252254)

Show all (12)

Other devices from SINTX Technologies Inc.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (8)

  • 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