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, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER (JWH) (10)

Premarket Exempt

No Yes

Clear

Ambition Knee System - 00840286838962 Catalog Number : 5110-0-1318

Device Description : Tibial Insert, CR, VitalitE, 3, 18mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286838979 Catalog Number : 5110-0-1321

Device Description : Tibial Insert, CR, VitalitE, 3, 21mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286838986 Catalog Number : 5110-0-1325

Device Description : Tibial Insert, CR, VitalitE, 3, 25mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286838993 Catalog Number : 5110-0-1330

Device Description : Tibial Insert, CR, VitalitE, 3, 30mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839006 Catalog Number : 5110-0-1410

Device Description : Tibial Insert, CR, VitalitE, 4, 10mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839013 Catalog Number : 5110-0-1412

Device Description : Tibial Insert, CR, VitalitE, 4, 12mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839020 Catalog Number : 5110-0-1414

Device Description : Tibial Insert, CR, VitalitE, 4, 14mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839037 Catalog Number : 5110-0-1416

Device Description : Tibial Insert, CR, VitalitE, 4, 16mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839044 Catalog Number : 5110-0-1418

Device Description : Tibial Insert, CR, VitalitE, 4, 18mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839051 Catalog Number : 5110-0-1421

Device Description : Tibial Insert, CR, VitalitE, 4, 21mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

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