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Versa-Dial® Shoulder System 407296

by Biomet Orthopedics, Inc.

Ref 407296

Versa-Dial® Shoulder System 407296 is a Class I device made by Biomet Orthopedics, Inc., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 889024-ZB002005-EK) and listed in FDA GUDID since 2 Apr 2022 (UDI-DI 00887868505645), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024-ZB002005-EK Basic UDI-DI 00887868505645UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868505645 UDI-DI Date2 Apr 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 889024-ZB002005-EK registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 00887868505645 listed 2 Apr 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00887868505645
  2. Registered EUDAMED 889024-ZB002005-EK

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Versa-Dial® Shoulder System
Generic name
Surgical screwdriver, reusable
Device name
VersaDial Head Trial Screwdriver
Model / Ref / Catalog
407296
Primary DI / UDI-DI
00887868505645
Basic UDI-DI
889024-ZB002005-EK
Direct marketing DI
00887868505645
FDA product code
HXX
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Surgical screwdriver, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical screwdriver, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)