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7712-20-60

by Zimmer, Inc.

Ref 00-7712-020-60

7712-20-60 (00-7712-020-60) is a device classified as Class I in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 1 Nov 2026 (Basic UDI-DI B-00889024654129), cleared under FDA 510(k) K192660 on 28 Feb 2020 and listed in FDA GUDID since 20 Jul 2016 (UDI-DI 00889024654129), 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) K192660

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-00889024654129 Basic UDI-DI 00889024654129UDI-DIDate1 Nov 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK192660 Date28 Feb 2020DecidedStatusActive
United StatesGUDID listing GUDID Number00889024654129 UDI-DI Date20 Jul 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00889024654129 registered 1 Nov 2026 Active
  • FDA 510(k) K192660 decided 28 Feb 2020 Active
  • FDA GUDID UDI-DI 00889024654129 listed 20 Jul 2016 Listed

Timeline

3 dated events

  1. Listed FDA GUDID 00889024654129
  2. Cleared FDA 510(k) K192660
  3. Registered EUDAMED B-00889024654129

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  • Withdrawn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
Zimmer® M/L Taper Hip Prosthesis
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
M/L Taper Rasps
Model / Ref / Catalog
00-7712-020-60, 7712-20-60
Primary DI / UDI-DI
00889024654129 EUDAMED
00889024132269 GUDID
Basic UDI-DI
B-00889024654129
510(k) Number
FDA product code
LZO, MEH
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3353
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 · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
00-7712-020-60
GUDID
7712-20-60
Primary DI / UDI-DIEUDAMED
00889024654129
GUDID
00889024132269
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00889024654129; FDA GUDID lists 00889024132269), so their flags are not compared. Device class is stated on each registry's own scale: Class I 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 (K192660)

and 8 more cleared under K192660

Similar devices in this category

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

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

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