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

TAPERSETCASE1 - 00840286839556 Catalog Number : TAPERSETCASE1

Device Description : Taperset Case 1

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

TAPERSETCASERDP - 00840286839563 Catalog Number : TAPERSETCASERDP

Device Description : RDP Taperset Instrument Case

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

UNISYNCASE1 - 00840286839570 Catalog Number : UNISYNCASE1

Device Description : UNISYN Case 1 Straight Reamers, Distal Pilot

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

UNISYNCASE2 - 00840286839587 Catalog Number : UNISYNCASE2

Device Description : UNISYN Case 2 Trial Necks and Heads

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

UNISYNCASE3 - 00840286839594 Catalog Number : UNISYNCASE3

Device Description : UNISYN Case 3 Disassembly and Removal Tools

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

UNISYNCASE4 - 00840286839600 Catalog Number : UNISYNCASE4

Device Description : UNISYN Case 4 Larger Reamers and Broaches

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

UNISYNCASE5 - 00840286839617 Catalog Number : UNISYNCASE5

Device Description : UNISYN Case 5 Bowed and Distal Pilots

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

UNISYNCASE6 - 00840286839624 Catalog Number : UNISYNCASE6

Device Description : UNISYN Case 6 Half Size Reamers

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

BIPOLAR28MM - 00840286839631 Catalog Number : BIPOLAR28MM

Device Description : 28MM BIPOLAR Instrument Case

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

CKSCOND1 - 00840286839648 Catalog Number : CKSCOND1

Device Description : CKS Condensed System Case 1

Device Class : 1

Duns Number: 085976260

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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