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Sp-2032

by Biomet Microfixation, Inc

Ref SP-2032

Sp-2032 is a device classified as Class IIa in the EU and Class I in the US made by Biomet Microfixation, Inc, registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI B-00841036284985) and listed in FDA GUDID since 30 Jun 2020 (UDI-DI 00841036284985), 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-00841036284985 Basic UDI-DI 00841036284985UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841036284985 UDI-DI Date30 Jun 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00841036284985 registered 23 Oct 2026 Active
  • FDA GUDID UDI-DI 00841036284985 listed 30 Jun 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841036284985
  2. Registered EUDAMED B-00841036284985

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  • Withdrawn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 knife
Device name
2.5 X 6mm Self-Drilling Modified Byrd Screw
Model / Ref / Catalog
SP-2032
Primary DI / UDI-DI
00841036284985
Basic UDI-DI
B-00841036284985
FDA product code
HWI
EMDN code
L090999 Orthopaedic surgery cutting instruments, reusable - other
GMDN term
Orthopaedic knife
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
Sterilisation method
Moist Heat or Steam Sterilization

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 knife

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER.

Other devices from Biomet Microfixation, Inc

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)