NUTECH SPINE, INC.

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

NuTech Spine - B946008010040 Catalog Number : 00.801.004

Device Description : Handle-Teardrop, Cannulated, LG Hudson (Fixed)

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NuFix - B946014000010 Catalog Number : 01.400.001

Device Description : 4.5mm NuFix Drill Bit

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NuFix II - B946021000010 Catalog Number : 02.100.001

Device Description : NuFix II Go/No-Go Gage

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NuFix II - B946024000010 Catalog Number : 02.400.001

Device Description : NuFix II Drill, 4.5mm

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NuFix II - B946024000030 Catalog Number : 02.400.003

Device Description : NuFix II Broach

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NuFix II - B946024000040 Catalog Number : 02.400.004

Device Description : NuFix II Drill, 4.5mm - Tapered

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NuFix II - B946024000050 Catalog Number : 02.400.005

Device Description : NuFix II Drill, 4.5mm-Tapered, Undersized

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NuFix II - B946024000060 Catalog Number : 02.400.006

Device Description : NuFix II Drill, 4.5mm - Stepped

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NuFix II - B946024000070 Catalog Number : 02.400.007

Device Description : NuFix II Drill, 4.5mm - Stepped, Undersized

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

SIFix - B946031000020 Catalog Number : 03.100.002

Device Description : 2.6mm Kwire 410mm-Round Tip

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

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