Skip to content

OsteoMed 320-1012-SP-02

by Osteomed Corp.

Ref 320-1012-SP-02

OsteoMed 320-1012-SP-02 is a device classified as Class IIa in the EU and Class II in the US made by Osteomed Corp., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-00845694073127) and listed in FDA GUDID since 22 Sep 2017 (UDI-DI 00845694073127), 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-00845694073127 Basic UDI-DI 00845694073127UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00845694073127 UDI-DI Date22 Sep 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00845694073127 registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI 00845694073127 listed 22 Sep 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00845694073127
  2. Registered EUDAMED B-00845694073127

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  • Withdrawn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
Acumed EUDAMED
OsteoMed GUDID
Generic name
General internal orthopaedic fixation system implantation kit
Device name
Instrument
Model / Ref / Catalog
320-1012-SP-02
Primary DI / UDI-DI
00845694073127
Basic UDI-DI
B-00845694073127
FDA product code
HWC
EMDN code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
Supplied sterileEUDAMED
No
GUDID
Yes
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 00845694073127: EUDAMED states No, FDA GUDID states Yes.
  • Sterilise before use UDI-DI 00845694073127: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class IIa 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: General internal orthopaedic fixation system implantation kit

Similar devices in this category

Other devices filed under INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from Osteomed Corp.

See all devices from Osteomed Corp. →

Properties

  • Supplied sterile NoEUDAMEDYesGUDID
  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)