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 - B6961014200170 Catalog Number :

Device Description : Tibial Insert 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 - B6961014200180 Catalog Number :

Device Description : MCL Retractor Left

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 - B6961014200190 Catalog Number :

Device Description : MCL Retractor Right

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 - B6961014200200 Catalog Number :

Device Description : MCL Retractor Pull Rod

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 - B6961014200220 Catalog Number :

Device Description : 3.5MM Hex 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 - B6961014200230 Catalog Number :

Device Description : TIBAIL TRAY EXTRACTOR

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 - B6961014200240 Catalog Number :

Device Description : SLAP HAMMER

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 - B6961014200250 Catalog Number :

Device Description : Z Retractor

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 - B6961014200290 Catalog Number :

Device Description : DYNAMIC GAP BALANCING GAGE

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 - B6961014200320 Catalog Number :

Device Description : MCL RETRACTOR LEFT

Device Class : 2

Duns Number: 056559377

Premarket Exempt : No

Product Code : JWH, MBH, OIY

Prescription Use : Yes

Device Count : 1

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