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Taperloc Complete 51-206130

by Biomet Orthopedics, Inc.

Taperloc Complete 51-206130 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K120030 on 17 Aug 2012 (1 earlier submission) and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00880304516861), 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 Number00880304516861 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK120030 Date17 Aug 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K120030 decided 17 Aug 2012 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00880304516861 listed 22 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K110400
  2. Cleared FDA 510(k) K120030
  3. Listed FDA GUDID 00880304516861

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Taperloc Complete
Generic name
Bone file/rasp, manual, reusable
Model / Ref / Catalog
51-206130
Primary DI / UDI-DI
00880304516861
510(k) Number
FDA product code
MEH, LPH, KWL, KWY, KWZ, LZO, JDI, OQG
GMDN term
Bone file/rasp, manual, reusable
Device class
Class II
Regulation number
888.3353, 888.3358, 888.3360, 888.3390, 888.3310, 888.3350
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Properties

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