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MectaScrew PEEK 05.05.0010

by Medacta International SA

Ref 05.05.0010

MectaScrew PEEK 05.05.0010 is a device classified as Class IIb 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-07630040723442), cleared under FDA 510(k) K190892 on 4 Jun 2019 and listed in FDA GUDID since 25 Jul 2019 (UDI-DI 07630040723442), 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) K190892

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-07630040723442 Basic UDI-DI 07630040723442UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630040723442 UDI-DI Date25 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK190892 Date4 Jun 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07630040723442 registered 6 Nov 2026 Active
  • FDA 510(k) K190892 decided 4 Jun 2019 Active
  • FDA GUDID UDI-DI 07630040723442 listed 25 Jul 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K190892
  2. Listed FDA GUDID 07630040723442
  3. Registered EUDAMED B-07630040723442

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  • Withdrawn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
MectaScrewPEEK Interference Screw 8x15 EUDAMED
MectaScrew PEEK GUDID
Generic name
Soft-tissue/mesh anchor, non-bioabsorbable
Device name
Sportsmed Interference screw
Model / reference
05.05.0010
Primary DI / UDI-DI
07630040723442
Basic UDI-DI
B-07630040723442
510(k) Number
FDA product code
MBI
EMDN code
P09120605 Interference screws
GMDN term
Soft-tissue/mesh 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: Soft-tissue/mesh anchor, non-bioabsorbable

Cleared under the same submission (K190892)

and 8 more cleared under K190892

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)