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OsteoMed 337-3514-SP-02

by Osteomed Corp.

Ref 337-3514-SP-02

OsteoMed 337-3514-SP-02 is a device classified as Class IIb in the EU and Class II in the US made by Osteomed Corp., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-00845694084789) and listed in FDA GUDID since 7 Aug 2015 (UDI-DI 00845694084789), 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-00845694084789 Basic UDI-DI 00845694084789UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00845694084789 UDI-DI Date7 Aug 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00845694084789 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00845694084789 listed 7 Aug 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00845694084789
  2. Registered EUDAMED B-00845694084789

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  • Withdrawn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
Screw
Model / Ref / Catalog
337-3514-SP-02
Primary DI / UDI-DI
00845694084789
Basic UDI-DI
B-00845694084789
FDA product code
HRS
EMDN code
P09120601 Cortical screws
GMDN term
Orthopaedic bone screw, non-bioabsorbable, sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Size
Length — 14 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIb 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 CORTICAL SCREWS.

Other devices from Osteomed Corp.

See all devices from Osteomed Corp. →

Properties

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