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Kit KneeTools V6 Knee+

by Pixee Medical

Ref KNK006Model Knee Orthopedic Instrument Kit

Kit KneeTools V6 Knee+ is an orthopaedic surgical procedure kit (EU MDR Class I; FDA Class II; FDA product code SBF, Orthopedic Augmented Reality) made by Pixee Medical, registered in EUDAMED on 20 Jul 2026 (Basic UDI-DI 376029703KNEEKITMA) and listed in FDA GUDID since 18 Apr 2025 (UDI-DI 03760297030483), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number376029703KNEEKITMA Basic UDI-DI 03760297030483UDI-DIDate20 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760297030483 UDI-DI Date18 Apr 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 376029703KNEEKITMA registered 20 Jul 2026 Active
  • FDA GUDID UDI-DI 03760297030483 listed 18 Apr 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03760297030483
  2. Registered EUDAMED 376029703KNEEKITMA

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  • Withdrawn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
KneeTools V6 Kit EUDAMED
Kit KneeTools V6 GUDID
Generic name
Orthopaedic surgical procedure kit, non-medicated, reusable
Model / reference
Knee Orthopedic Instrument Kit EUDAMED
KNK006 EUDAMED
Knee+ GUDID
Primary DI / UDI-DI
03760297030483
Basic UDI-DI
376029703KNEEKITMA
FDA product code
SBF
EMDN code
Z12130480 Stereotactic orthopaedic surgery instruments - hardware accessories
GMDN term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
For naviguated knee arthroplasty
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Knee Orthopedic Instrument Kit
KNK006
GUDID
Knee+
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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 surgical procedure kit, non-medicated, reusable

Similar devices in this category

Other devices filed under STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Pixee Medical

See all devices from Pixee Medical →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)