OPTIMOTION IMPLANTS LLC

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

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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, 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 - B6961014100510 Catalog Number :

Device Description : Femoral Impactor

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 - B6961014100520 Catalog Number :

Device Description : Femoral Driver

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 - B6961014100540 Catalog Number :

Device Description : Modular Handle

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 - B6961014100550 Catalog Number :

Device Description : Pin Puller

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 - B6961014100560 Catalog Number :

Device Description : Angel Wing

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 - B6961014100580 Catalog Number :

Device Description : FEMORAL TRIAL INSERTER

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 - B6961014100610 Catalog Number :

Device Description : CURVED OSTEOTOME

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 - B6961014110010 Catalog Number :

Device Description : Femoral Chamfer Cut Block 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 - B6961014110020 Catalog Number :

Device Description : Femoral Chamfer Cut Block 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 - B6961014110030 Catalog Number :

Device Description : Femoral Chamfer Cut Block Sz 3

Device Class : 2

Duns Number: 056559377

Premarket Exempt : No

Product Code : JWH, MBH, OIY

Prescription Use : Yes

Device Count : 1

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