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Revolution Counter CP461636

by Biomet Orthopedics, Inc.

Ref CP461636

Revolution Counter CP461636 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 889024-ZB002384-GD), cleared under FDA 510(k) K140509 on 28 May 2014 and listed in FDA GUDID since 1 Feb 2023 (UDI-DI 00887868552779), active as of 7 Nov 2026.

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

CE MDR 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) K140509

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/MDR EUDAMED Number889024-ZB002384-GD Basic UDI-DI 00887868552779UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868552779 UDI-DI Date1 Feb 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK140509 Date28 May 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024-ZB002384-GD registered 29 Oct 2026 Active
  • FDA 510(k) K140509 decided 28 May 2014 Active
  • FDA GUDID UDI-DI 00887868552779 listed 1 Feb 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K140509
  2. Listed FDA GUDID 00887868552779
  3. Registered EUDAMED 889024-ZB002384-GD

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Revolution Counter
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
OSS Revolution Counter
Model / reference
CP461636
Primary DI / UDI-DI
00887868552779
Basic UDI-DI
889024-ZB002384-GD
Direct marketing DI
00887868552779
510(k) Number
FDA product code
KRO
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3510
EU registration type
Standard device
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: Orthopaedic prosthesis implantation positioning instrument, reusable

Cleared under the same submission (K140509)

and 8 more cleared under K140509

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
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)