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 - 00840286839068 Catalog Number : 5110-0-1425

Device Description : Tibial Insert, CR, VitalitE, 4, 25mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839075 Catalog Number : 5110-0-1430

Device Description : Tibial Insert, CR, VitalitE, 4, 30mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839082 Catalog Number : 5110-0-1510

Device Description : Tibial Insert, CR, VitalitE, 5, 10mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839099 Catalog Number : 5110-0-1512

Device Description : Tibial Insert, CR, VitalitE, 5, 12mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839105 Catalog Number : 5110-0-1514

Device Description : Tibial Insert, CR, VitalitE, 5, 14mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839112 Catalog Number : 5110-0-1516

Device Description : Tibial Insert, CR, VitalitE, 5, 16mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839129 Catalog Number : 5110-0-1518

Device Description : Tibial Insert, CR, VitalitE, 5, 18mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839136 Catalog Number : 5110-0-1521

Device Description : Tibial Insert, CR, VitalitE, 5, 21mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839143 Catalog Number : 5110-0-1525

Device Description : Tibial Insert, CR, VitalitE, 5, 25mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839150 Catalog Number : 5110-0-1530

Device Description : Tibial Insert, CR, VitalitE, 5, 30mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

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