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Comprehensive® 110031442

by Zimmer, Inc.

Part of a family of 6 devices: see the family page

Ref 110031442

Comprehensive® 110031442 is a device classified as Class IIa in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 31 Oct 2026 (Basic UDI-DI 889024AR8ZP), cleared under FDA 510(k) K181611 on 24 Sep 2018 and listed in FDA GUDID since 22 Feb 2019 (UDI-DI 00887868231742), 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) K181611

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 Number889024AR8ZP Basic UDI-DI 00887868231742UDI-DIDate31 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868231742 UDI-DI Date22 Feb 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK181611 Date24 Sep 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024AR8ZP registered 31 Oct 2026 Active
  • FDA 510(k) K181611 decided 24 Sep 2018 Active
  • FDA GUDID UDI-DI 00887868231742 listed 22 Feb 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K181611
  2. Listed FDA GUDID 00887868231742
  3. Registered EUDAMED 889024AR8ZP

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  • Withdrawn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
Comprehensive®
Generic name
Reverse shoulder cup prosthesis trial, reusable
Device name
Comprehensive Reverse Mini Bearing Trials
Model / Ref / Catalog
110031442
Primary DI / UDI-DI
00887868231742
Basic UDI-DI
889024AR8ZP
Direct marketing DI
00887868231742
510(k) Number
FDA product code
KWS, PHX, PAO, KWT
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Reverse shoulder cup prosthesis trial, reusable
Device class
Class IIa 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 IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Reverse shoulder cup prosthesis trial, reusable

Cleared under the same submission (K181611)

and 8 more cleared under K181611

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
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)