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) (10) Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer (NJD) (10)

Premarket Exempt

Clear

Engage Partial Knee System - B6951100131130 Catalog Number :

Device Description : Tibial Insert, Size 1, Left Medial, 13MM

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951100131590 Catalog Number :

Device Description : Tibial Insert, Size 1, Right Medial, 9MM

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951100131600 Catalog Number :

Device Description : Tibial Insert, Size 1, Right Medial, 10MM

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951100131610 Catalog Number :

Device Description : Tibial Insert, Size 1, Right Medial, 11MM

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951100131630 Catalog Number :

Device Description : Tibial Insert, Size 1, Right Medial, 13MM

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951100132090 Catalog Number :

Device Description : Tibial Insert, Size 2, Left Medial, 9MM

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951100132100 Catalog Number :

Device Description : Tibial Insert, Size 2, Left Medial, 10MM

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951100132110 Catalog Number :

Device Description : Tibial Insert, Size 2, Left Medial, 11MM

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951100132130 Catalog Number :

Device Description : Tibial Insert, Size 2, Left Medial, 13MM

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951100132590 Catalog Number :

Device Description : Tibial Insert, Size 2, Right Medial, 9MM

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

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