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) (8) Orthopedic manual surgical instrument (LXH) (2)

Premarket Exempt

No Yes

Clear

Ambition Knee System - 00840286839167 Catalog Number : 5110-0-1610

Device Description : Tibial Insert, CR, VitalitE, 6, 10mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839174 Catalog Number : 5110-0-1612

Device Description : Tibial Insert, CR, VitalitE, 6, 12mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839181 Catalog Number : 5110-0-1614

Device Description : Tibial Insert, CR, VitalitE, 6, 14mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839198 Catalog Number : 5110-0-1616

Device Description : Tibial Insert, CR, VitalitE, 6, 16mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839204 Catalog Number : 5110-0-1618

Device Description : Tibial Insert, CR, VitalitE, 6, 18mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839211 Catalog Number : 5110-0-1621

Device Description : Tibial Insert, CR, VitalitE, 6, 21mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839228 Catalog Number : 5110-0-1625

Device Description : Tibial Insert, CR, VitalitE, 6, 25mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

Ambition Knee System - 00840286839235 Catalog Number : 5110-0-1630

Device Description : Tibial Insert, CR, VitalitE, 6, 30mm

Device Class : 2

Duns Number: 085976260

Premarket Exempt : No

Product Code : JWH

Prescription Use : Yes

Device Count : 1

CHSCASE1 - 00840286839334 Catalog Number : CHSCASE1

Device Description : CHS Case 1 Canal Reamers

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

CHSCASE2 - 00840286839341 Catalog Number : CHSCASE2

Device Description : CHS Case 2 Press Fit and Cemented Broach

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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