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PEEK CF Interference Screw 10034

by Parcus Medical LLC

Ref 10034Model PEEK CF Interference Screw

PEEK CF Interference Screw 10034 is a device classified as Class IIb in the EU and Class II in the US made by Parcus Medical LLC, registered in EUDAMED on 13 May 2026 (Basic UDI-DI B-00816342020305) and listed in FDA GUDID since 7 Dec 2021 (UDI-DI 00816342020305), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00816342020305 Basic UDI-DI 00816342020305UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816342020305 UDI-DI Date7 Dec 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00816342020305 registered 13 May 2026 Active
  • FDA GUDID UDI-DI 00816342020305 listed 7 Dec 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816342020305
  2. Registered EUDAMED B-00816342020305

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  • Withdrawn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
Screw,IF,Can,Pk,10X25 EUDAMED
PEEK CF Interference Screw GUDID
Generic name
Tendon/ligament bone anchor, non-bioabsorbable
Model / reference
10034, PEEK CF Interference Screw
Primary DI / UDI-DI
00816342020305
Basic UDI-DI
B-00816342020305
FDA product code
HWC
EMDN code
P09120605 Interference screws
GMDN term
Tendon/ligament bone anchor, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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: Tendon/ligament bone anchor, non-bioabsorbable

Similar devices in this category

Other devices filed under INTERFERENCE SCREWS.

Other devices from Parcus Medical LLC

See all devices from Parcus Medical LLC →

Properties

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