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Alliance® SBHA4101

by Zimmer, Inc.

Ref SBHA4101

Alliance® SBHA4101 is a device classified as Class I in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 889024AQ7ZJ), cleared under FDA 510(k) K191814 on 23 Oct 2019 and listed in FDA GUDID since 20 Nov 2019 (UDI-DI 00889024574762), 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) K191814

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 Number889024AQ7ZJ Basic UDI-DI 00889024574762UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024574762 UDI-DI Date20 Nov 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191814 Date23 Oct 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024AQ7ZJ registered 30 Oct 2026 Active
  • FDA 510(k) K191814 decided 23 Oct 2019 Active
  • FDA GUDID UDI-DI 00889024574762 listed 20 Nov 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K191814
  2. Listed FDA GUDID 00889024574762
  3. Registered EUDAMED 889024AQ7ZJ

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  • Withdrawn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
Alliance®
Generic name
Orthopaedic implantation sleeve, reusable
Device name
Alliance Glenoid Planer-Reamer Sleeve
Model / Ref / Catalog
SBHA4101
Primary DI / UDI-DI
00889024574762
Basic UDI-DI
889024AQ7ZJ
Direct marketing DI
00889024574762
510(k) Number
FDA product code
KWS, KWT
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic implantation sleeve, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3660, 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 implantation sleeve, reusable

Cleared under the same submission (K191814)

and 8 more cleared under K191814

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)