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ACDF Stand Alone Cervical 03.18.104

by Medacta International

Ref 03.18.104

ACDF Stand Alone Cervical 03.18.104 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-07630040725583), cleared under FDA 510(k) K203076 on 6 Nov 2020 (1 earlier submission) and listed in FDA GUDID since 23 Jun 2020 (UDI-DI 07630040725583), 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-07630040725583 Basic UDI-DI 07630040725583UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK203076 Date6 Nov 2020DecidedStatusActive
United StatesGUDID listing GUDID Number07630040725583 UDI-DI Date23 Jun 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07630040725583 registered 30 Oct 2026 Active
  • FDA 510(k) K203076 decided 6 Nov 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07630040725583 listed 23 Jun 2020 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K192906
  2. Listed FDA GUDID 07630040725583
  3. Cleared FDA 510(k) K203076
  4. Registered EUDAMED B-07630040725583

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  • Withdrawn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 TiPEEK Cage 15x13x8x7° EUDAMED
ACDF Stand Alone Cervical GUDID
Generic name
Metallic spinal interbody fusion cage
Device name
Spine Mecta-C Stand Alone TiPeek cage
Model / reference
03.18.104
Primary DI / UDI-DI
07630040725583
Basic UDI-DI
B-07630040725583
510(k) Number
FDA product code
OVE
EMDN code
P09070101 Spinal cages
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 CAGES.

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)