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Fusion Lateral Instrument Set 38-SLAPHAMMER

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 9 Nov 2026. What this means

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840311258185 UDI-DI Date23 Oct 2026ListedStatusListed 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  • Withdrawn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
Fusion Lateral Instrument Set
Generic name
General internal orthopaedic fixation system implantation kit
Model / reference
38-SLAPHAMMER
Primary DI / UDI-DI
00840311258185
FDA product code
HWA
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Xtant Medical Holdings, Inc.

See all devices from Xtant Medical Holdings, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number

Other properties (11)

  • Supplied 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