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Mendec Spine Kit 13C2000

by Tecres

Ref 13C2000

Mendec Spine Kit 13C2000 is a device classified as Class III in the EU and Class II in the US made by Tecres, registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI 80314970390P8), cleared under FDA 510(k) K062452 on 21 Sep 2006 and listed in FDA GUDID since 6 Oct 2015 (UDI-DI 28031497000521), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

4 Nov 2030

CE MDR certificate

FDA recalls

None found

in data synced 7 Nov 2026

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

510(k) K062452

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/MDR EUDAMED Number80314970390P8 Basic UDI-DI 28031497000521UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number28031497000521 UDI-DI Date6 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK062452 Date21 Sep 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 80314970390P8 registered 25 Sep 2026 Active
  • FDA 510(k) K062452 decided 21 Sep 2006 Active
  • FDA GUDID UDI-DI 28031497000521 listed 6 Oct 2015 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 773665 Active Amended

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    19 Feb 2026
    Expires
    4 Nov 2030
    Reason
    Other

Timeline

3 dated events

  1. Cleared FDA 510(k) K062452
  2. Listed FDA GUDID 28031497000521
  3. Registered EUDAMED 80314970390P8

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Mendec Spine Kit
Generic name
Orthopaedic cement preparation/delivery kit
Model / reference
13C2000
Primary DI / UDI-DI
28031497000521
Basic UDI-DI
80314970390P8
510(k) Number
FDA product code
NDN
EMDN code
K010399 Spinal endotherapy devices - other
GMDN term
Orthopaedic cement preparation/delivery kit
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3027
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class III 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: Orthopaedic cement preparation/delivery kit

Similar devices in this category

Other devices filed under SPINAL ENDOTHERAPY DEVICES.

Other devices from Tecres

See all devices from Tecres →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Contains animal tissues or cells
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)