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 - 00840286800006 Catalog Number : 1701-0-0042

Device Description : CHS, CS2, Acetabular Shell, Ti, Ti Plasma, Hemispherical, 3-Hole, 42mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Acetabular Shell - 00840286800013 Catalog Number : 1701-0-0044

Device Description : CHS, CS2, Acetabular Shell, Ti, Ti Plasma, Hemispherical, 3-Hole, 44mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Acetabular Shell - 00840286800020 Catalog Number : 1701-0-0046

Device Description : CHS, CS2, Acetabular Shell, Ti, Ti Plasma, Hemispherical, 3-Hole, 46mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Acetabular Shell - 00840286800037 Catalog Number : 1701-0-0048

Device Description : CHS, CS2, Acetabular Shell, Ti, Ti Plasma, Hemispherical, 3-Hole, 48mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Acetabular Shell - 00840286800044 Catalog Number : 1701-0-0050

Device Description : CHS, CS2, Acetabular Shell, Ti, Ti Plasma, Hemispherical, 3-Hole, 50mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Acetabular Shell - 00840286800051 Catalog Number : 1701-0-0052

Device Description : CHS, CS2, Acetabular Shell, Ti, Ti Plasma, Hemispherical, 3-Hole, 52mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Acetabular Shell - 00840286800068 Catalog Number : 1701-0-0054

Device Description : CHS, CS2, Acetabular Shell, Ti, Ti Plasma, Hemispherical, 3-Hole, 54mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Acetabular Shell - 00840286800075 Catalog Number : 1701-0-0056

Device Description : CHS, CS2, Acetabular Shell, Ti, Ti Plasma, Hemispherical, 3-Hole, 56mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Acetabular Shell - 00840286800082 Catalog Number : 1701-0-0058

Device Description : CHS, CS2, Acetabular Shell, Ti, Ti Plasma, Hemispherical, 3-Hole, 58mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

Acetabular Shell - 00840286800099 Catalog Number : 1701-0-0060

Device Description : CHS, CS2, Acetabular Shell, Ti, Ti Plasma, Hemispherical, 3-Hole, 60mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : LPH

Prescription Use : Yes

Device Count : 1

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