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ZipTight™ Fixation System 904837

by Biomet Orthopedics, Inc.

Ref 904837

ZipTight™ Fixation System 904837 is a device classified as Class IIa in the EU and Class I in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI B-00880304491885) and listed in FDA GUDID since 5 May 2017 (UDI-DI 00880304491885), active as of 24 Oct 2026.

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

CE MDD

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00880304491885 Basic UDI-DI 00880304491885UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00880304491885 UDI-DI Date5 May 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00880304491885 registered 20 Oct 2026 Active
  • FDA GUDID UDI-DI 00880304491885 listed 5 May 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00880304491885
  2. Registered EUDAMED B-00880304491885

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
ZipTight™ Fixation System
Generic name
Ligament reconstruction instrument set, reusable
Device name
AC Joint Procedure System Kit
Model / Ref / Catalog
904837
Primary DI / UDI-DI
00880304491885
Basic UDI-DI
B-00880304491885
FDA product code
LXH
EMDN code
L010101 Monoblock surgical scalpels, reusable
GMDN term
Ligament reconstruction instrument set, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Ligament reconstruction instrument set, reusable

Similar devices

Other devices filed under FDA product code LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT).

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)