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Mecta-C Ti mark 03.28.328

by Medacta International SA

Ref 03.28.328

Mecta-C Ti mark 03.28.328 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 30 Oct 2026 (Basic UDI-DI B-07630040718783), cleared under FDA 510(k) K172587 on 18 Sep 2017 and listed in FDA GUDID since 25 Oct 2021 (UDI-DI 07630040718783), 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) K172587

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-07630040718783 Basic UDI-DI 07630040718783UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630040718783 UDI-DI Date25 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK172587 Date18 Sep 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07630040718783 registered 30 Oct 2026 Active
  • FDA 510(k) K172587 decided 18 Sep 2017 Active
  • FDA GUDID UDI-DI 07630040718783 listed 25 Oct 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K172587
  2. Listed FDA GUDID 07630040718783
  3. Registered EUDAMED B-07630040718783

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  • Withdrawn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 TiPEEK dome shaped 15x18x7 L5° - Ti mark EUDAMED
Mecta-C Ti mark GUDID
Generic name
Metallic spinal interbody fusion cage
Device name
Spine Mecta-C TiPeek cage
Model / reference
03.28.328
Primary DI / UDI-DI
07630040718783
Basic UDI-DI
B-07630040718783
510(k) Number
FDA product code
ODP
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 (K172587)

and 8 more cleared under K172587

Similar devices in this category

Other devices filed under SPINAL CAGES.

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)