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 - B6951510410050 Catalog Number :

Device Description : Femoral Trial Right 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 - B695151041005A0 Catalog Number :

Device Description : Femoral Trial Right 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 - B6951510410060 Catalog Number :

Device Description : Femoral Trial Right Medial Size 6

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B695151041006A0 Catalog Number :

Device Description : Femoral Trial Right Medial Size 6

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951510410070 Catalog Number :

Device Description : Femoral Trial Right Medial Size 7

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B695151041007A0 Catalog Number :

Device Description : Femoral Trial Right Medial Size 7

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951510550090 Catalog Number :

Device Description : Insert Sizer 9mm

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951510550100 Catalog Number :

Device Description : Insert Sizer 10mm

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951510550110 Catalog Number :

Device Description : Insert Sizer 11mm

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

Engage Partial Knee System - B6951510550130 Catalog Number :

Device Description : Insert Sizer 13mm

Device Class : 2

Duns Number: 088177182

Premarket Exempt : No

Product Code : NJD, HSX

Prescription Use : Yes

Device Count : 1

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