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Identity™ SBHS0197

by Zimmer, Inc.

Ref SBHS0197

Identity™ SBHS0197 is a device classified as Class I in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI 889024BPY3R), cleared under FDA 510(k) K213856 on 15 Sep 2022 and listed in FDA GUDID since 27 Sep 2022 (UDI-DI 00889024627666), active as of 24 Oct 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213856

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024BPY3R Basic UDI-DI 00889024627666UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024627666 UDI-DI Date27 Sep 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK213856 Date15 Sep 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024BPY3R registered 20 Oct 2026 Active
  • FDA 510(k) K213856 decided 15 Sep 2022 Active
  • FDA GUDID UDI-DI 00889024627666 listed 27 Sep 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K213856
  2. Listed FDA GUDID 00889024627666
  3. Registered EUDAMED 889024BPY3R

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  • Withdrawn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
Identity™
Generic name
Orthopaedic implant aiming/guiding block, reusable
Device name
IDENTITY Resect Block Ext Post
Model / Ref / Catalog
SBHS0197
Primary DI / UDI-DI
00889024627666
Basic UDI-DI
889024BPY3R
510(k) Number
FDA product code
PHX, HSD, MBF, KWT, KWS
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic implant aiming/guiding block, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3660, 888.3690, 888.3670, 888.3650
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 I
GUDID
Class II

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 implant aiming/guiding block, reusable

Cleared under the same submission (K213856)

and 8 more cleared under K213856

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)