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Taperloc® Complete 51-203130

by Biomet Orthopedics, Inc.

Ref 51-203130

Taperloc® Complete 51-203130 is a device classified as Class IIa in the EU and Class II in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00887868508509), cleared under FDA 510(k) K120030 on 17 Aug 2012 and listed in FDA GUDID since 26 May 2022 (UDI-DI 00887868508509), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K120030

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00887868508509 Basic UDI-DI 00887868508509UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868508509 UDI-DI Date26 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK120030 Date17 Aug 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00887868508509 registered 29 Oct 2026 Active
  • FDA 510(k) K120030 decided 17 Aug 2012 Active
  • FDA GUDID UDI-DI 00887868508509 listed 26 May 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K120030
  2. Listed FDA GUDID 00887868508509
  3. Registered EUDAMED B-00887868508509

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Taperloc® Complete
Generic name
Bone file/rasp, manual, reusable
Device name
HP Taperloc Complete Reduced Distal Broach
Model / Ref / Catalog
51-203130
Primary DI / UDI-DI
00887868508509
Basic UDI-DI
B-00887868508509
510(k) Number
FDA product code
KWL, KWY, JDI, LZO, KWZ, MEH, OQG, LPH
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Bone file/rasp, manual, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3360, 888.3390, 888.3350, 888.3353, 888.3310, 888.3358
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Bone file/rasp, manual, reusable

Cleared under the same submission (K120030)

and 8 more cleared under K120030

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)