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K-Wire SN46

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 Number00810111225311 UDI-DI Date20 Nov 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  • Withdrawn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
K-Wire
Generic Name
Orthopaedic intraoperative positioning pin, single-use
Model / Reference
SN46
Primary DI / UDI-DI
00810111225311
FDA Product Code
HWE
GMDN Term
Orthopaedic intraoperative positioning pin, single-use
Device Class
Class I
Regulation Number
878.4820
GUDID distribution status
In Commercial Distribution

Other devices from Treace Medical Concepts, Inc.

See all devices from Treace Medical Concepts, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

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