PIXEE MEDICAL

Address:18 rue Alain Savary,Besancon Doubs,FR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Orthopedic Stereotaxic Instrument (OLO) (6) System, Image Processing, Radiological (LLZ) (1) Tray, Surgical, Instrument (FSM) (1)

Premarket Exempt

Yes No

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Long Pointer - 03760297030131 Catalog Number : KNI011

Device Description : Reusable instrument for Total Knee Arthroplasty

Device Class : 2

Duns Number: 270195749

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Portal - 03760297030148 Catalog Number : KNP001

Device Description : Software for Total Knee Arthroplasty

Device Class : 2

Duns Number: 270195749

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Slim Bone Reference - 03760297030155 Catalog Number : KNI012

Device Description : Reusable instrument for Total Knee Arthroplasty

Device Class : 2

Duns Number: 270195749

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Slim Universal Cutting Guide - 03760297030162 Catalog Number : KNI013

Device Description : Reusable instrument for Total Knee Arthroplasty

Device Class : 2

Duns Number: 270195749

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Right Proximal Cutting Guide - 03760297030179 Catalog Number : KNI014

Device Description : Reusable instrument for Total Knee Arthroplasty

Device Class : 2

Duns Number: 270195749

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Left Proximal Cutting Guide - 03760297030186 Catalog Number : KNI015

Device Description : Reusable instrument for Total Knee Arthroplasty

Device Class : 2

Duns Number: 270195749

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Instruments box - 03760297030193 Catalog Number : BIN002

Device Description : Storage box for orthopedic surgical instruments

Device Class : 1

Duns Number: 270195749

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

FX Shoulder Positioning System - 03760297030209 Catalog Number :

Device Description : Planning software for total shoulder arthroplasty

Device Class : 2

Duns Number: 270195749

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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