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Calibrated Spade Tip 110007425

by Biomet Orthopedics, Inc.

Ref 110007425

Calibrated Spade Tip 110007425 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-00887868463020) and listed in FDA GUDID since 23 Jul 2021 (UDI-DI 00887868463020), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00887868463020 Basic UDI-DI 00887868463020UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868463020 UDI-DI Date23 Jul 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00887868463020 registered 20 Oct 2026 Active
  • FDA GUDID UDI-DI 00887868463020 listed 23 Jul 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00887868463020
  2. Registered EUDAMED B-00887868463020

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  • Withdrawn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
Calibrated Spade Tip
Generic name
Orthopaedic guidewire, reusable
Device name
SM Spade Tip Suture Passer Pin
Model / Ref / Catalog
110007425
Primary DI / UDI-DI
00887868463020
Basic UDI-DI
B-00887868463020
FDA product code
GFC
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Orthopaedic guidewire, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
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: Orthopaedic guidewire, reusable

Similar devices

Also classified as Orthopaedic guidewire, reusable.

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

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