Shalby Advanced Technologies, Inc.

Address:1115 Windfield Way,El Dorado Hills,CA,95762,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, semi-constrained, metal/polymer, cemented (JDI) (7) PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED (LPH) (3)

Premarket Exempt

No Yes

Clear

Consensus Hip System - 00840286800402 Catalog Number : 0007-1-2802

Device Description : Femoral Head, 28mm, ±0mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JDI

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800419 Catalog Number : 0007-1-2803

Device Description : Femoral Head, 28mm, +5mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JDI

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800426 Catalog Number : 0007-1-2804

Device Description : Femoral Head, 28mm, +10mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JDI

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800433 Catalog Number : 0007-1-3201

Device Description : Femoral Head, 32mm, -5mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JDI

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800440 Catalog Number : 0007-1-3202

Device Description : Femoral Head, 32mm, ±0mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JDI

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800457 Catalog Number : 0007-1-3203

Device Description : Femoral Head, 32mm, +5mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JDI

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800464 Catalog Number : 0007-1-3204

Device Description : Femoral Head, 32mm, +10mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JDI

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800471 Catalog Number : 0007-1-3601

Device Description : Femoral Head, 36mm, -5mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800488 Catalog Number : 0007-1-3602

Device Description : Femoral Head, 36mm, ±0mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800495 Catalog Number : 0007-1-3603

Device Description : Femoral Head, 36mm, +5mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

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