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MectaScrew C 05.05.0114

by Medacta International SA

Ref 05.05.0114

MectaScrew C 05.05.0114 is a device classified as Class III in the EU and Class II in the US made by Medacta International SA, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-07630345703422), cleared under FDA 510(k) K203335 on 3 Feb 2022 and listed in FDA GUDID since 7 Feb 2022 (UDI-DI 07630345703422), active as of 12 Nov 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 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K203335

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07630345703422 Basic UDI-DI 07630345703422UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630345703422 UDI-DI Date7 Feb 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK203335 Date3 Feb 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07630345703422 registered 6 Nov 2026 Active
  • FDA 510(k) K203335 decided 3 Feb 2022 Active
  • FDA GUDID UDI-DI 07630345703422 listed 7 Feb 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K203335
  2. Listed FDA GUDID 07630345703422
  3. Registered EUDAMED B-07630345703422

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  • Withdrawn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
MectaScrewC Composite Interference Screw 12x35 EUDAMED
MectaScrew C GUDID
Generic name
Tendon/ligament bone anchor, bioabsorbable
Device name
Sportsmed Composite Interference screw
Model / reference
05.05.0114
Primary DI / UDI-DI
07630345703422
Basic UDI-DI
B-07630345703422
510(k) Number
FDA product code
HWC
EMDN code
P09120605 Interference screws
GMDN term
Tendon/ligament bone anchor, bioabsorbable
Device class
Class III 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 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: Tendon/ligament bone anchor, bioabsorbable

Cleared under the same submission (K203335)

and 8 more cleared under K203335

Similar devices in this category

Other devices filed under INTERFERENCE SCREWS.

Other devices from Medacta International SA

See all devices from Medacta International SA →

Properties

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