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) (8) Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (LZO) (2) Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (LPH) (2)

Premarket Exempt

No

Clear

Modal Total Knee System - B035CPM32024005N0 Catalog Number : CPM-3202-4005-N

Device Description : Tibial Augment SZ 0

Device Class : 2

Duns Number: 081983825

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Modal Total Knee System - B035CPM32024105N0 Catalog Number : CPM-3202-4105-N

Device Description : Tibial Augment SZ 1

Device Class : 2

Duns Number: 081983825

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Modal Total Knee System - B035CPM32024205N0 Catalog Number : CPM-3202-4205-N

Device Description : Tibial Augment SZ 2

Device Class : 2

Duns Number: 081983825

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Modal Total Knee System - B035CPM32024305N0 Catalog Number : CPM-3202-4305-N

Device Description : Tibial Augment SZ 3

Device Class : 2

Duns Number: 081983825

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Modal Total Knee System - B035CPM32024405N0 Catalog Number : CPM-3202-4405-N

Device Description : Tibial Augment SZ 4

Device Class : 2

Duns Number: 081983825

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Modal Total Knee System - B035CPM32024505N0 Catalog Number : CPM-3202-4505-N

Device Description : Tibial Augment SZ 5

Device Class : 2

Duns Number: 081983825

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Modal Total Knee System - B035CPM32024605N0 Catalog Number : CPM-3202-4605-N

Device Description : Tibial Augment SZ 6

Device Class : 2

Duns Number: 081983825

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Modal Total Knee System - B035G9101000 Catalog Number : G910100

Device Description : Modular Handle

Device Class : 2

Duns Number: 081983825

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Modal Total Hip System - B035M110006001 Catalog Number :

Device Description : Taper Stem, Std Offset Sz 6.0

Device Class : 2

Duns Number: 081983825

Premarket Exempt : No

Product Code : LZO, LPH

Prescription Use : Yes

Device Count : 1

Modal Total Hip System - B035M110007501 Catalog Number :

Device Description : Taper Stem, Std Offset Sz 7.5

Device Class : 2

Duns Number: 081983825

Premarket Exempt : No

Product Code : LZO, LPH

Prescription Use : Yes

Device Count : 1

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