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MyKnee LBS 4.1623

by Medacta International

Ref 4.1623Model Knee Cutting guide TKA - not sterile

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764014274KSP0902N00BP Basic UDI-DI 07630030851070UDI-DIDate20 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630030851070 UDI-DI Date13 Jan 2021ListedStatusListed 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 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
MyKnee LBS FemCutBL_Assembly -CT- GMK -RM- #3 EUDAMED
MyKnee LBS GUDID
Generic Name
Orthopaedic prosthesis implantation positioning instrument, single-use
Model / Reference
4.1623, Knee Cutting guide TKA - not sterile
Primary DI / UDI-DI
07630030851070
Basic UDI-DI
764014274KSP0902N00BP
510(k) Number
FDA Product Code
JWH
EMDN Code
K01020114 Minimally invasive surgery guides, single-use
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.3560
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, single-use

Cleared under the same submission (K093806)

Show all (12)

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Implantable: No
  • 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