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) (9) Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented (LZO) (1)

Premarket Exempt

No Yes

Clear

Consensus Hip System - 00840286800303 Catalog Number : 0006-0-3203

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

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800310 Catalog Number : 0007-0-2801

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 - 00840286800327 Catalog Number : 0007-0-2802

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 - 00840286800334 Catalog Number : 0007-0-2803

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 - 00840286800341 Catalog Number : 0007-0-2804

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 - 00840286800358 Catalog Number : 0007-1-2201

Device Description : Femoral Head, 22mm, -3mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JDI

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800365 Catalog Number : 0007-1-2202

Device Description : Femoral Head, 22mm, ±0mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JDI

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800372 Catalog Number : 0007-1-2203

Device Description : Femoral Head, 22mm, +3mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JDI

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800389 Catalog Number : 0007-1-2204

Device Description : Femoral Head, 22mm, +6mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JDI

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800396 Catalog Number : 0007-1-2801

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

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JDI

Prescription Use : Yes

Device Count : 1

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