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6301-07-055

by Zimmer, Inc.

Ref 6301-07-055

6301-07-055 is a device classified as Class IIb in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-00889024365872) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 00889024365872), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00889024365872 Basic UDI-DI 00889024365872UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024365872 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00889024365872 registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 00889024365872 listed 24 Sep 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00889024365872
  2. Registered EUDAMED B-00889024365872

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  • Withdrawn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

Generic name
Orthopaedic bone screw, non-bioabsorbable, sterile
Device name
HP Acetabular Screws_BONE SCREW 6.5 CANCL Implants
Model / Ref / Catalog
6301-07-055
Primary DI / UDI-DI
00889024365872
Basic UDI-DI
B-00889024365872
FDA product code
HWC
EMDN code
P09088099 Hip prostheses - other accessories
GMDN term
Orthopaedic bone screw, non-bioabsorbable, sterile
Device class
Class IIb 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
Size
Length — 55 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIb 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 screw, non-bioabsorbable, sterile

Similar devices in this category

Other devices filed under HIP PROSTHESES - OTHER ACCESSORIES.

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Properties

  • Sterilise before use
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)