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OsteoMed 316-1601

by Osteomed Corp.

Ref 316-1601

OsteoMed 316-1601 is a device classified as Class IIa in the EU and Class II in the US made by Osteomed Corp., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00842528102053) and listed in FDA GUDID since 15 May 2017 (UDI-DI 00842528102053), 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-00842528102053 Basic UDI-DI 00842528102053UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842528102053 UDI-DI Date15 May 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00842528102053 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00842528102053 listed 15 May 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00842528102053
  2. Registered EUDAMED B-00842528102053

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  • Withdrawn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
Orthopaedic bone screw, non-bioabsorbable, sterile
Device name
Wires
Model / Ref / Catalog
316-1601
Primary DI / UDI-DI
00842528102053
Basic UDI-DI
B-00842528102053
FDA product code
HWC
EMDN code
P09120399 Bone fixation wires - other
GMDN term
Orthopaedic bone screw, non-bioabsorbable, sterile
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
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 1.6 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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: Orthopaedic bone screw, non-bioabsorbable, sterile

Similar devices in this category

Other devices filed under BONE FIXATION WIRES - OTHER.

Other devices from Osteomed Corp.

See all devices from Osteomed Corp. →

Properties

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