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/ceramic/polymer, cemented or non-porous, uncemented (LZO) (6) Prosthesis, hip, semi-constrained (metal cemented acetabular component) (JDL) (3) PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED (LPH) (1)

Premarket Exempt

No Yes

Clear

Consensus Hip System - 00840286800501 Catalog Number : 0007-1-3604

Device Description : Femoral Head, 36mm, +10mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800518 Catalog Number : 0008-0-2801

Device Description : Femoral Head, Biolox, 28mm, -3.5mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800525 Catalog Number : 0008-0-2802

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

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800532 Catalog Number : 0008-0-2803

Device Description : Femoral Head, Biolox, 28mm, +3.5mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800549 Catalog Number : 0008-0-3201

Device Description : Femoral Head, Biolox, 32mm, -3.5mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800556 Catalog Number : 0008-0-3202

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

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800563 Catalog Number : 0008-0-3203

Device Description : Femoral Head, Biolox, 32mm, +3.5mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LZO

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800570 Catalog Number : 0009-0-0010

Device Description : Distal Centralizer, 10mm

Device Class : 3

Duns Number: 085976260

Premarket Exempt : No

Product Code : JDL

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800587 Catalog Number : 0009-0-0011

Device Description : Distal Centralizer, 11mm

Device Class : 3

Duns Number: 085976260

Premarket Exempt : No

Product Code : JDL

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800594 Catalog Number : 0009-0-0012

Device Description : Distal Centralizer, 12mm

Device Class : 3

Duns Number: 085976260

Premarket Exempt : No

Product Code : JDL

Prescription Use : Yes

Device Count : 1

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