OPTIMOTION IMPLANTS LLC

Address:6052 Turkey Lake Road,Orlando,FL,32819,US

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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, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer (MBH) (10) Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive (OIY) (10) Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (JWH) (10)

Premarket Exempt

Clear

Optimotion Blue CR HCCR Total Knee System - B6961014110040 Catalog Number :

Device Description : Femoral Chamfer Cut Block Sz 4

Device Class : 2

Duns Number: 056559377

Premarket Exempt : No

Product Code : JWH, MBH, OIY

Prescription Use : Yes

Device Count : 1

Optimotion Blue CR HCCR Total Knee System - B6961014110050 Catalog Number :

Device Description : Femoral Chamfer Cut Block Sz 5

Device Class : 2

Duns Number: 056559377

Premarket Exempt : No

Product Code : JWH, MBH, OIY

Prescription Use : Yes

Device Count : 1

Optimotion Blue CR HCCR Total Knee System - B6961014110060 Catalog Number :

Device Description : Femoral Chamfer Cut Block Sz 6

Device Class : 2

Duns Number: 056559377

Premarket Exempt : No

Product Code : JWH, MBH, OIY

Prescription Use : Yes

Device Count : 1

Optimotion Blue CR HCCR Total Knee System - B6961014110070 Catalog Number :

Device Description : Femoral Chamfer Cut Block Sz 7

Device Class : 2

Duns Number: 056559377

Premarket Exempt : No

Product Code : JWH, MBH, OIY

Prescription Use : Yes

Device Count : 1

Optimotion Blue CR HCCR Total Knee System - B6961014110080 Catalog Number :

Device Description : Femoral Chamfer Cut Block Sz 8

Device Class : 2

Duns Number: 056559377

Premarket Exempt : No

Product Code : JWH, MBH, OIY

Prescription Use : Yes

Device Count : 1

Optimotion Blue CR HCCR Total Knee System - B6961014120010 Catalog Number :

Device Description : Femoral Trial Universal Sz 1

Device Class : 2

Duns Number: 056559377

Premarket Exempt : No

Product Code : JWH, MBH, OIY

Prescription Use : Yes

Device Count : 1

Optimotion Blue CR HCCR Total Knee System - B6961014120020 Catalog Number :

Device Description : Femoral Trial Universal Sz 2

Device Class : 2

Duns Number: 056559377

Premarket Exempt : No

Product Code : JWH, MBH, OIY

Prescription Use : Yes

Device Count : 1

Optimotion Blue CR HCCR Total Knee System - B6961014120030 Catalog Number :

Device Description : Femoral Trial Universal Sz 3

Device Class : 2

Duns Number: 056559377

Premarket Exempt : No

Product Code : JWH, MBH, OIY

Prescription Use : Yes

Device Count : 1

Optimotion Blue CR HCCR Total Knee System - B6961014120040 Catalog Number :

Device Description : Femoral Trial Universal Sz 4

Device Class : 2

Duns Number: 056559377

Premarket Exempt : No

Product Code : JWH, MBH, OIY

Prescription Use : Yes

Device Count : 1

Optimotion Blue CR HCCR Total Knee System - B6961014120050 Catalog Number :

Device Description : Femoral Trial Universal Sz 5

Device Class : 2

Duns Number: 056559377

Premarket Exempt : No

Product Code : JWH, MBH, OIY

Prescription Use : Yes

Device Count : 1

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