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ACDF Stand Alone Cervical 03.18.608

by Medacta International

Ref 03.18.608

ACDF Stand Alone Cervical 03.18.608 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-07630040726467), cleared under FDA 510(k) K203076 on 6 Nov 2020 (1 earlier submission) and listed in FDA GUDID since 26 Jun 2020 (UDI-DI 07630040726467), 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) K203076

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07630040726467 Basic UDI-DI 07630040726467UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK203076 Date6 Nov 2020DecidedStatusActive
United StatesGUDID listing GUDID Number07630040726467 UDI-DI Date26 Jun 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07630040726467 registered 30 Oct 2026 Active
  • FDA 510(k) K203076 decided 6 Nov 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07630040726467 listed 26 Jun 2020 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K192906
  2. Listed FDA GUDID 07630040726467
  3. Cleared FDA 510(k) K203076
  4. Registered EUDAMED B-07630040726467

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  • Withdrawn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
Mecta-C SA Drill Screw Lock Ø4.2x16 (1x) EUDAMED
ACDF Stand Alone Cervical GUDID
Generic name
Metallic spinal interbody fusion cage
Device name
Spine Mecta-C Stand Alone Screws Lock
Model / reference
03.18.608
Primary DI / UDI-DI
07630040726467
Basic UDI-DI
B-07630040726467
510(k) Number
FDA product code
OVE
EMDN code
P09070199 Spinal fusion systems - other
GMDN term
Metallic spinal interbody fusion cage
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3080
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: Metallic spinal interbody fusion cage

Cleared under the same submission (K192906)

and 8 more cleared under K192906

Cleared under the same submission (K203076)

and 8 more cleared under K203076

Similar devices in this category

Other devices filed under SPINAL FUSION SYSTEMS - OTHER.

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)