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Bioscrew Xtralok C8043

by Conmed Corporation

Ref C8043

Bioscrew Xtralok C8043 is a device classified as Class III in the EU and Class II in the US made by Conmed Corporation, registered in EUDAMED on 19 Jun 2026 (Basic UDI-DI B-20845854013493), cleared under FDA 510(k) K050497 on 25 Mar 2005 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 20845854013493), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K050497

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-20845854013493 Basic UDI-DI 20845854013493UDI-DIDate19 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20845854013493 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK050497 Date25 Mar 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-20845854013493 registered 19 Jun 2026 Active
  • FDA 510(k) K050497 decided 25 Mar 2005 Active
  • FDA GUDID UDI-DI 20845854013493 listed 24 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K050497
  2. Listed FDA GUDID 20845854013493
  3. Registered EUDAMED B-20845854013493

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Bioscrew Xtralok
Generic name
Bioabsorbable orthopaedic bone screw
Device name
Bioabsorbable Implants
Model / Ref / Catalog
C8043
Primary DI / UDI-DI
20845854013493
Basic UDI-DI
B-20845854013493
510(k) Number
FDA product code
HWC
EMDN code
P09120605 Interference screws
GMDN term
Bioabsorbable orthopaedic bone screw
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe
Size
Outer Diameter — 8 Millimeter
Length — 40 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Bioabsorbable orthopaedic bone screw

Cleared under the same submission (K050497)

Similar devices in this category

Other devices filed under INTERFERENCE SCREWS.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

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