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Fully Threaded Cancellous Screw 8557-61-035

by Biomet Orthopedics, Inc.

Ref 855761035

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024-ZB001254-FC Basic UDI-DI 00887868447938UDI-DIDate24 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868447938 UDI-DI Date13 Jul 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Fully Threaded Cancellous Screw
Generic Name
Orthopaedic bone screw, non-bioabsorbable, sterile
Device Name
ALPS LF 6_5mm cancellous screw sterile
Model / Ref / Catalog
855761035, 8557-61-035
Primary DI / UDI-DI
00887868447938
Basic UDI-DI
889024-ZB001254-FC
FDA Product Code
JDW, HTY, HWC, HTN, HRS, HSB, KTT, LXT
EMDN Code
P09120602 Cancellous screws
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, sterile
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3040, 888.3030, 888.3020
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
855761035
GUDID
8557-61-035
Device ClassEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Orthopaedic bone screw, non-bioabsorbable, sterile

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No