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Identity™ SAHH3616

by Zimmer, Inc.

Ref SAHH3616

Identity™ SAHH3616 is a device classified as Class III in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 2 Oct 2025 (Basic UDI-DI 889024BPQ39) with CE/MDR certificate MDR 766966 valid until 3 Apr 2030, cleared under FDA 510(k) K213856 on 15 Sep 2022 and listed in FDA GUDID since 27 Sep 2022 (UDI-DI 00889024626539), active as of 22 Oct 2026.

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

CE MDR 510(k)

Valid until

3 Apr 2030

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

510(k) K213856

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 766966 Date9 Jul 2026IssuedStatusActive expires 3 Apr 2030
United StatesGUDID listing GUDID Number00889024626539 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 889024BPQ39 registered 2 Oct 2025 Active· +1 more in the status table
  • FDA 510(k) K213856 decided 15 Sep 2022 Active
  • FDA GUDID UDI-DI 00889024626539 listed 27 Sep 2022 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 766966 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    9 Jul 2026
    Expires
    3 Apr 2030
    Reason
    Other

Timeline

5 dated events

  1. Cleared FDA 510(k) K213856
  2. Listed FDA GUDID 00889024626539
  3. Registered EUDAMED 889024BPQ39
  4. Certificate issued EUDAMED MDR 766966
  5. Certificate expires EUDAMED MDR 766966

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  • Withdrawn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
Stem-fixed metallic humeral head prosthesis
Device name
IDENTITY Humeral Heads
Model / Ref / Catalog
SAHH3616
Primary DI / UDI-DI
00889024626539
Basic UDI-DI
889024BPQ39
510(k) Number
FDA product code
KWS, HSD, MBF, PHX, KWT
EMDN code
P090104010101 Epiphysary humeral components for anatomical prostheses - humeral heads
GMDN term
Stem-fixed metallic humeral head prosthesis
Device class
Class III 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
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: Stem-fixed metallic humeral head prosthesis

Cleared under the same submission (K213856)

and 8 more cleared under K213856

Similar devices in this category

Other devices filed under EPIPHYSARY HUMERAL COMPONENTS FOR ANATOMICAL PROSTHESES - HUMERAL HEADS.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)