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Mecta-C Cervical Plate System 03.70.062

by Medacta International

Ref 03.70.062

Mecta-C Cervical Plate System 03.70.062 is a device classified as Class IIb in the EU and Class II in the US made by Medacta International, registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-07630030840401), cleared under FDA 510(k) K140361 on 12 Jun 2014 and listed in FDA GUDID since 18 Oct 2015 (UDI-DI 07630030840401), active as of 7 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K140361

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07630030840401 Basic UDI-DI 07630030840401UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630030840401 UDI-DI Date18 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK140361 Date12 Jun 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07630030840401 registered 30 Oct 2026 Active
  • FDA 510(k) K140361 decided 12 Jun 2014 Active
  • FDA GUDID UDI-DI 07630030840401 listed 18 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K140361
  2. Listed FDA GUDID 07630030840401
  3. Registered EUDAMED B-07630030840401

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  • Withdrawn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
Var. Self-Tapping Screw Dia. 4x21mm (2x) - Sterile EUDAMED
Mecta-C Cervical Plate System GUDID
Generic name
Spinal bone screw, non-bioabsorbable
Device name
Spine Cervical plates screw
Model / reference
03.70.062
Primary DI / UDI-DI
07630030840401
Basic UDI-DI
B-07630030840401
510(k) Number
FDA product code
KWQ
EMDN code
P09070301 Cervical fixation systems
GMDN term
Spinal bone screw, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3060
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

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: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K140361)

and 8 more cleared under K140361

Similar devices in this category

Other devices filed under CERVICAL FIXATION SYSTEMS.

Other devices from Medacta International

See all devices from Medacta International →

Properties

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