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, POROUS UNCEMENTED (LPH) (10)

Premarket Exempt

No Yes

Clear

Acetabular Shell - 00840286800105 Catalog Number : 1701-0-0062

Device Description : CHS, CS2, Acetabular Shell, Ti, Ti Plasma, Hemispherical, 3-Hole, 62mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Acetabular Shell - 00840286800112 Catalog Number : 1701-0-0064

Device Description : CHS, CS2, Acetabular Shell, Ti, Ti Plasma, Hemispherical, 3-Hole, 64mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Acetabular Shell - 00840286800129 Catalog Number : 1701-0-0066

Device Description : CHS, CS2, Acetabular Shell, Ti, Ti Plasma, Hemispherical, 3-Hole, 66mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Acetabular Shell - 00840286800136 Catalog Number : 1701-0-0068

Device Description : CHS, CS2, Acetabular Shell, Ti, Ti Plasma, Hemispherical, 3-Hole, 68mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800143 Catalog Number : 0005-0-2801

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

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800150 Catalog Number : 0005-0-2802

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

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800167 Catalog Number : 0005-0-2803

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

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800174 Catalog Number : 0005-0-3201

Device Description : Femoral Head, Biolox, delta, 32mm, -4mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800181 Catalog Number : 0005-0-3202

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

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Consensus Hip System - 00840286800198 Catalog Number : 0005-0-3203

Device Description : Femoral Head, Biolox, delta, 32mm, +4mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

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