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HammerFiX 132-04000-S

by Extremity Medical, LLC

HammerFiX 132-04000-S is a Class II device made by Extremity Medical, LLC, cleared under FDA 510(k) K133636 on 28 Mar 2014 and listed in FDA GUDID since 29 Oct 2026 (UDI-DI 00842078100035), active as of 9 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 9 Nov 2026

Documents

510(k) K133636

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00842078100035 UDI-DI Date29 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK133636 Date28 Mar 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K133636 decided 28 Mar 2014 Active
  • FDA GUDID UDI-DI 00842078100035 listed 29 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K133636
  2. Listed FDA GUDID 00842078100035

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
HammerFiX
Generic name
Orthopaedic surgical procedure kit, non-medicated, single-use
Model / reference
132-04000-S
Primary DI / UDI-DI
00842078100035
510(k) Number
FDA product code
HWC
GMDN term
Orthopaedic surgical procedure kit, non-medicated, single-use
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K133636)

and 5 more cleared under K133636

Other devices from Extremity Medical, LLC

See all devices from Extremity Medical, LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)