Engage UNI LLC

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Filters

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

Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer (HSX) (5) Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer (NJD) (5)

Premarket Exempt

Clear

Engage Partial Knee System - B6951520010000 Catalog Number :

Device Description : General Tray 1

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951520020000 Catalog Number :

Device Description : General Tray 2

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951520040000 Catalog Number :

Device Description : Left Tray

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951520050000 Catalog Number :

Device Description : Right Tray

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951520100000 Catalog Number :

Device Description : Revision Tray

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

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