MODAL MANUFACTURING 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, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (JWH) (10)

Premarket Exempt

Clear

Modal Total Knee System - B035M341100601 Catalog Number :

Device Description : Patella Trial 29mm

Device Class : 2

Duns Number: 081983825

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Modal Total Knee System - B035M341100701 Catalog Number :

Device Description : Patella Trial 32mm

Device Class : 2

Duns Number: 081983825

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Modal Total Knee System - B035M341100801 Catalog Number :

Device Description : Patella Trial 35mm

Device Class : 2

Duns Number: 081983825

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Modal Total Knee System - B035M341100901 Catalog Number :

Device Description : Patella Trial 38mm

Device Class : 2

Duns Number: 081983825

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Modal Total Knee System - B035M341101001 Catalog Number : M-3411-0100

Device Description : XXL Patellar Trial 41mm

Device Class : 2

Duns Number: 081983825

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Modal Total Knee System - B035M342050001 Catalog Number :

Device Description : Patellar Resection Clamp

Device Class : 2

Duns Number: 081983825

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Modal Total Knee System - B035M342050011 Catalog Number :

Device Description : Patellar Drill & Cement Clamp

Device Class : 2

Duns Number: 081983825

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Modal Total Knee System - B035M342050021 Catalog Number :

Device Description : Patellar Drill Guide 29mm

Device Class : 2

Duns Number: 081983825

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Modal Total Knee System - B035M342050031 Catalog Number :

Device Description : Patellar Cement Clamp

Device Class : 2

Duns Number: 081983825

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Modal Total Knee System - B035M342050041 Catalog Number :

Device Description : Patellar Drill

Device Class : 2

Duns Number: 081983825

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

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