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GMK Sphere Total Knee System 02.12.0310FL

by Medacta International

Ref 02.12.0310FL

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07630030826337 Basic UDI-DI 07630030826337UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630030826337 UDI-DI Date18 Nov 2014ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
GMK-SPHERE Tibial Insert - Flex S3L - 10 mm EUDAMED
GMK Sphere Total Knee System GUDID
Generic Name
Tibial insert
Device Name
Knee Tibial insert fixed total with secure screw
Model / Reference
02.12.0310FL
Primary DI / UDI-DI
07630030826337
Basic UDI-DI
B-07630030826337
510(k) Number
FDA Product Code
JWH
EMDN Code
P090903020202, P090905020202
GMDN Term
Tibial insert
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3560
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
SterileEUDAMED
No
GUDID
Yes

Related devices

Category: Tibial insert

Cleared under the same submission (K121416)

Show all (12)

Other devices from Medacta International

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Properties

  • Sterile NoEUDAMEDYesGUDID
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No