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59-0034-01

by Biomet Microfixation, Inc

59-0034-01 is a Class II device made by Biomet Microfixation, Inc, cleared under FDA 510(k) K112671 on 4 May 2012 (1 earlier submission) and listed in FDA GUDID since 12 Jul 2016 (UDI-DI 00841036211226), active as of 23 Oct 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 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841036211226 UDI-DI Date12 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK112671 Date4 May 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112671 decided 4 May 2012 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00841036211226 listed 12 Jul 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K062510
  2. Cleared FDA 510(k) K112671
  3. Listed FDA GUDID 00841036211226

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Device sterilization/disinfection container, reusable
Model / Ref / Catalog
59-0034-01
Primary DI / UDI-DI
00841036211226
510(k) Number
FDA product code
KCT, FRG
GMDN term
Device sterilization/disinfection container, reusable
Device class
Class II
Regulation number
880.6850
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Device sterilization/disinfection container, reusable

Cleared under the same submission (K062510)

and 5 more cleared under K062510

Cleared under the same submission (K112671)

and 5 more cleared under K112671

Similar devices in this category

Other devices filed under Device sterilization/disinfection container, reusable.

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)