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TMC SpeedTMT SK64

by Treace Medical Concepts, 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810111225199 UDI-DI Date12 Dec 2025ListedStatusListed 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  • Withdrawn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
TMC SpeedTMT
Generic Name
Orthopaedic bone staple, non-adjustable
Model / Reference
SK64
Primary DI / UDI-DI
00810111225199
FDA Product Code
JDR, HWC, HRS
GMDN Term
Orthopaedic bone staple, non-adjustable
Device Class
Class II
Regulation Number
888.3030, 888.3040
GUDID distribution status
In Commercial Distribution

Other devices from Treace Medical Concepts, Inc.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration 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
  • Manufacturing Date: No