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Max Vpck-Wire 231211105

by Biomet Orthopedics, Inc.

Ref 231211105

Max Vpck-Wire 231211105 is a device classified as Class IIa in the EU and Class II in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 24 Oct 2026 (Basic UDI-DI B-00880304804821), cleared under FDA 510(k) K160058 on 9 Mar 2016 and listed in FDA GUDID since 27 Jun 2016 (UDI-DI 00880304804821), active as of 7 Nov 2026.

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

CE MDD 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) K160058

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/MDD EUDAMED NumberB-00880304804821 Basic UDI-DI 00880304804821UDI-DIDate24 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00880304804821 UDI-DI Date27 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK160058 Date9 Mar 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00880304804821 registered 24 Oct 2026 Active
  • FDA 510(k) K160058 decided 9 Mar 2016 Active
  • FDA GUDID UDI-DI 00880304804821 listed 27 Jun 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K160058
  2. Listed FDA GUDID 00880304804821
  3. Registered EUDAMED B-00880304804821

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Max Vpck-Wire
Generic name
Orthopaedic bone wire
Model / Ref / Catalog
231211105
Primary DI / UDI-DI
00880304804821
Basic UDI-DI
B-00880304804821
510(k) Number
FDA product code
HWC
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Orthopaedic bone wire
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
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: Orthopaedic bone wire

Cleared under the same submission (K160058)

and 8 more cleared under K160058

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)