NUTECH SPINE, INC.

Address:2231 20th Avenue South,Birmingham,AL,35223,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

Yes

Clear

SIFix - B946031002600 Catalog Number : 03.100.260

Device Description : 2.6mm Kwire 317mm-Round Tip

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

SIFix - B946031100010 Catalog Number : 03.110.001

Device Description : SIFix Depth Gauge

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

SIFix - B946032000010 Catalog Number : 03.200.001

Device Description : Dilator 1

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

SIFix - B946032000020 Catalog Number : 03.200.002

Device Description : Dilator 2

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

SIFix - B946032000030 Catalog Number : 03.200.003

Device Description : Dilator 3

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

SIFix - B946032000040 Catalog Number : 03.200.004

Device Description : Dilator 4

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

SIFix - B946032000050 Catalog Number : 03.200.005

Device Description : Dilator 5 Assy

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

SIFix - B946033000010 Catalog Number : 03.300.001

Device Description : SIFix Drill Guide Assy

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

SIFix - B9460330000110 Catalog Number : 03.300.001

Device Description : SIFix Drill Guide Assy

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

SIFix - B946034000010 Catalog Number : 03.400.001

Device Description : SIFix Drill Bit 42mm

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

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