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

Orthopedic manual surgical instrument (LXH) (10)

Premarket Exempt

No Yes

Clear

CS2CASE2 - 00840286839457 Catalog Number : CS2CASE2

Device Description : CS2 CASE 2 Acetabular Trials

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

CS2CASE3 - 00840286839464 Catalog Number : CS2CASE3

Device Description : CS2 CASE 3 Drills Case

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

RKSCASE1 - 00840286839471 Catalog Number : RKSCASE1

Device Description : General Instruments

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

RKSCASE2 - 00840286839488 Catalog Number : RKSCASE2

Device Description : Left Femoral

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

RKSCASE3 - 00840286839495 Catalog Number : RKSCASE3

Device Description : Right Femoral

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

RKSCASE4 - 00840286839501 Catalog Number : RKSCASE4

Device Description : Stem Trials

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

RKSCASE5 - 00840286839518 Catalog Number : RKSCASE5

Device Description : Augment Trials

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

RKSCASE6 - 00840286839525 Catalog Number : RKSCASE6

Device Description : Tibal Alignment

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

RKSCASE7 - 00840286839532 Catalog Number : RKSCASE7

Device Description : Left Tibia

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

RKSCASE8 - 00840286839549 Catalog Number : RKSCASE8

Device Description : Right Tibia

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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