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OsteoMed 220-0322

by Osteomed Corp.

Part of a family of 196 devices: see the family page

Ref 220-0322Model INSTRUMENTS

OsteoMed 220-0322 is a Class I device made by Osteomed Corp., registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI 0806378BUDIO58SB) and listed in FDA GUDID since 22 Sep 2017 (UDI-DI 00845694006552), active as of 24 Oct 2026.

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

CE MDR

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0806378BUDIO58SB Basic UDI-DI 00845694006552UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00845694006552 UDI-DI Date22 Sep 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0806378BUDIO58SB registered 5 Oct 2026 Active
  • FDA GUDID UDI-DI 00845694006552 listed 22 Sep 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00845694006552
  2. Registered EUDAMED 0806378BUDIO58SB

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  • Withdrawn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
Acumed EUDAMED
OsteoMed GUDID
Generic name
General internal orthopaedic fixation system implantation kit
Model / Ref / Catalog
220-0322, INSTRUMENTS
Primary DI / UDI-DI
00845694006552
Basic UDI-DI
0806378BUDIO58SB
FDA product code
KIJ
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 I
Regulation number
878.4820
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)