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802204001

by Zimmer, Inc.

Ref 802204001

802204001 is a device classified as Class III in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-00889024498921), cleared under FDA 510(k) K183457 on 5 Nov 2019 and listed in FDA GUDID since 19 Mar 2020 (UDI-DI 00889024498921), 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) K183457

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-00889024498921 Basic UDI-DI 00889024498921UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024498921 UDI-DI Date19 Mar 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK183457 Date5 Nov 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00889024498921 registered 30 Oct 2026 Active
  • FDA 510(k) K183457 decided 5 Nov 2019 Active
  • FDA GUDID UDI-DI 00889024498921 listed 19 Mar 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K183457
  2. Listed FDA GUDID 00889024498921
  3. Registered EUDAMED B-00889024498921

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  • Withdrawn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 Biomet™ CoCr Head
Generic name
Metallic femoral head prosthesis
Device name
Heads ZB 12/14 Taper COCR Head Implants
Model / Ref / Catalog
802204001
Primary DI / UDI-DI
00889024498921
Basic UDI-DI
B-00889024498921
510(k) Number
FDA product code
KWZ, OQG, KWY, LPH
EMDN code
P090804050202 Metal femoral heads, total hip replacement
GMDN term
Metallic femoral head prosthesis
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3310, 888.3358, 888.3390
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Metallic femoral head prosthesis

Cleared under the same submission (K183457)

and 8 more cleared under K183457

Similar devices in this category

Other devices filed under METAL FEMORAL HEADS, TOTAL HIP REPLACEMENT.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)