Ortho Development Corporation

Address:12800 South 271 West,Draper,UT,84020,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, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER (JWH) (10)

Premarket Exempt

No Yes

Clear

Balanced Knee System - 00822409003174 Catalog Number :

Device Description : Size 3 Tibial Tray Porous Pegged

Device Class : 2

Duns Number: 876542390

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Balanced Knee System - 00822409003181 Catalog Number :

Device Description : Size 4 Tibial Tray Porous Pegged

Device Class : 2

Duns Number: 876542390

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Balanced Knee System - 00822409003198 Catalog Number :

Device Description : Size 5 Tibial Tray Porous Pegged

Device Class : 2

Duns Number: 876542390

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Balanced Knee System - 00822409003204 Catalog Number :

Device Description : Size 6 Tibial Tray Porous Pegged

Device Class : 2

Duns Number: 876542390

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Balanced Knee System - 00822409003211 Catalog Number :

Device Description : Size 7 Tibial Tray Porous Pegged

Device Class : 2

Duns Number: 876542390

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Balance Knee Revision System - 00822409003228 Catalog Number :

Device Description : Size 1 Modular Tibial Tray Neutral

Device Class : 2

Duns Number: 876542390

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Balance Knee Revision System - 00822409003235 Catalog Number :

Device Description : Size 2 Modular Tibial Tray Neutral

Device Class : 2

Duns Number: 876542390

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Balance Knee Revision System - 00822409003242 Catalog Number :

Device Description : Size 3 Modular Tibial Tray Neutral

Device Class : 2

Duns Number: 876542390

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Balance Knee Revision System - 00822409003259 Catalog Number :

Device Description : Size 4 Modular Tibial Tray Neutral

Device Class : 2

Duns Number: 876542390

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Balance Knee Revision System - 00822409003266 Catalog Number :

Device Description : Size 5 Modular Tibial Tray Neutral

Device Class : 2

Duns Number: 876542390

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

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