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 - B6961014200070 Catalog Number :

Device Description : Tibial Tray Central Drill 16mm

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 - B6961014200080 Catalog Number :

Device Description : Tibial Stylus 2 and 11mm

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 - B6961014200090 Catalog Number :

Device Description : Tibial Tray Central Drill 17mm

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 - B6961014200100 Catalog Number :

Device Description : Auxillary Peg Punch Short

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 - B6961014200110 Catalog Number :

Device Description : EM Guide Resection Guide Connector 3 deg

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 - B6961014200120 Catalog Number :

Device Description : EM Guide Resection Guide Connector 0 deg

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 - B6961014200130 Catalog Number :

Device Description : Tibial Keel Punch Guide Sz 1, 2, 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 - B6961014200140 Catalog Number :

Device Description : Auxillary Peg Punch Long

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 - B6961014200150 Catalog Number :

Device Description : Gap Gauge

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 - B6961014200160 Catalog Number :

Device Description : Tibial Base Plate Impactor

Device Class : 2

Duns Number: 056559377

Premarket Exempt : No

Product Code : JWH, MBH, OIY

Prescription Use : Yes

Device Count : 1

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