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Locking Cortical Screw 8161-35-060

by Biomet Orthopedics, Inc.

Ref 816135060

Locking Cortical Screw 8161-35-060 (816135060) is a device classified as Class IIb 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-00887868547218) and listed in FDA GUDID since 6 Sep 2022 (UDI-DI 00887868547218), 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-00887868547218 Basic UDI-DI 00887868547218UDI-DIDate24 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868547218 UDI-DI Date6 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00887868547218 registered 24 Oct 2026 Active
  • FDA GUDID UDI-DI 00887868547218 listed 6 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00887868547218
  2. Registered EUDAMED B-00887868547218

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  • Withdrawn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
Locking Cortical Screw
Generic name
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device name
ALPS T15 3_5mm cortical locking screw
Model / Ref / Catalog
816135060, 8161-35-060
Primary DI / UDI-DI
00887868547218
Basic UDI-DI
B-00887868547218
FDA product code
HSB, KTT, HWC, HRS, LXT, HTN, HTY, JDW
EMDN code
P09120601 Cortical screws
GMDN term
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3020, 888.3030, 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 · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
816135060
GUDID
8161-35-060
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, non-sterile

Similar devices in this category

Other devices filed under CORTICAL SCREWS.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

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