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 - B6951100037000 Catalog Number :

Device Description : Femoral Component, Size 7 - Right Medial

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951100037100 Catalog Number :

Device Description : Femoral Component, Size 7 - Left Medial

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951100111000 Catalog Number :

Device Description : Tibial Anchor Stem, Size 1-2

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951100112000 Catalog Number :

Device Description : Tibial Anchor Stem, Size 3-4

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951100113000 Catalog Number :

Device Description : Tibial Anchor Stem, Size 5-6

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951100121000 Catalog Number :

Device Description : Affinium 3D Coated Tibial Tray, Left Medial, Size 1

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951100121500 Catalog Number :

Device Description : Affinium 3D Coated Tibial Tray, Right Medial, Size 1

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951100122000 Catalog Number :

Device Description : Affinium 3D Coated Tibial Tray, Left Medial, Size 2

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951100122500 Catalog Number :

Device Description : Affinium 3D Coated Tibial Tray, Right Medial, Size 2

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951100123000 Catalog Number :

Device Description : Affinium 3D Coated Tibial Tray, Left Medial, Size 3

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

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