Ortho Development Corporation

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, hip, hemi-, femoral, metal/polymer, cemented or uncemented (KWY) (8) Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous (MBL) (8) Prosthesis, hip, hemi-, femoral, metal (KWL) (8) PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED (LPH) (8) Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented (LZO) (8) Prosthesis, hip, semi-constrained, metal/polymer, cemented (JDI) (8) PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER (JWH) (2)

Premarket Exempt

No Yes

Clear

Alpine - 00822409000333 Catalog Number :

Device Description : Alpine Cemented Stem 16 STD

Device Class : 2

Duns Number: 876542390

Premarket Exempt : No

Product Code : MBL, KWY, KWL, LPH, JDI, LZO

Prescription Use : Yes

Device Count : 1

Alpine - 00822409000395 Catalog Number :

Device Description : Alpine Cemented Stem 10 EXT

Device Class : 2

Duns Number: 876542390

Premarket Exempt : No

Product Code : LPH, JDI, MBL, LZO, KWL, KWY

Prescription Use : Yes

Device Count : 1

Alpine - 00822409000401 Catalog Number :

Device Description : Alpine Cemented Stem 11 EXT

Device Class : 2

Duns Number: 876542390

Premarket Exempt : No

Product Code : KWL, JDI, MBL, LPH, LZO, KWY

Prescription Use : Yes

Device Count : 1

Alpine - 00822409000418 Catalog Number :

Device Description : Alpine Cemented Stem 12 EXT

Device Class : 2

Duns Number: 876542390

Premarket Exempt : No

Product Code : JDI, LZO, KWL, LPH, KWY, MBL

Prescription Use : Yes

Device Count : 1

Alpine - 00822409000425 Catalog Number :

Device Description : Alpine Cemented Stem 13 EXT

Device Class : 2

Duns Number: 876542390

Premarket Exempt : No

Product Code : KWY, MBL, KWL, JDI, LZO, LPH

Prescription Use : Yes

Device Count : 1

Alpine - 00822409000432 Catalog Number :

Device Description : Alpine Cemented Stem 14 EXT

Device Class : 2

Duns Number: 876542390

Premarket Exempt : No

Product Code : KWL, KWY, JDI, LPH, LZO, MBL

Prescription Use : Yes

Device Count : 1

Alpine - 00822409000449 Catalog Number :

Device Description : Alpine Cemented Stem 15 EXT

Device Class : 2

Duns Number: 876542390

Premarket Exempt : No

Product Code : MBL, LZO, JDI, LPH, KWY, KWL

Prescription Use : Yes

Device Count : 1

Alpine - 00822409000456 Catalog Number :

Device Description : Alpine Cemented Stem 16 EXT

Device Class : 2

Duns Number: 876542390

Premarket Exempt : No

Product Code : LZO, LPH, JDI, MBL, KWL, KWY

Prescription Use : Yes

Device Count : 1

Balanced Knee System - 00822409003150 Catalog Number :

Device Description : Size 1 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 - 00822409003167 Catalog Number :

Device Description : Size 2 Tibial Tray Porous Pegged

Device Class : 2

Duns Number: 876542390

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

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