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 - B6951510380000 Catalog Number :

Device Description : Femoral Downsizing Guide, Universal, 2-3 & 5-8

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951510390000 Catalog Number :

Device Description : Posterior Prep Guide - Universal

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951510400020 Catalog Number :

Device Description : Femoral Trial 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 - B695151040002A0 Catalog Number :

Device Description : Femoral Trial 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 - B6951510400030 Catalog Number :

Device Description : Femoral Trial Left Medial Size 3

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B695151040003A0 Catalog Number :

Device Description : Femoral Trial Left Medial Size 3

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951510400040 Catalog Number :

Device Description : Femoral Trial Left Medial Size 4

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B695151040004A0 Catalog Number :

Device Description : Femoral Trial Left Medial Size 4

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951510400050 Catalog Number :

Device Description : Femoral Trial Left Medial Size 5

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B695151040005A0 Catalog Number :

Device Description : Femoral Trial Left Medial Size 5

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

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