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

NuFix - B946NF10060 Catalog Number : NF-1006

Device Description : Carbon Fiber Handle

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NuFix - B946NF10070 Catalog Number : NF-1007

Device Description : 5.0mm Drill Bit

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NuFix - B946NF10090 Catalog Number : NF-1009

Device Description : Guide Pins

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NuFix II - B946NFII2000 Catalog Number : NFII-200

Device Description : Drill Bushing Center Hole Rev. 01

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NuFix II - B946NFII200D0 Catalog Number : NF-200-D

Device Description : Drill Bushing Two Holes Rev. 01

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NuFix II - B946NFII200DIR0 Catalog Number : NFII-200-D

Device Description : Drill Bushing Two Holes

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NuFix II - B946NFII200IR0 Catalog Number : NFII-200

Device Description : Drill Bushing Center Hole

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NuFix II - B946NFII3000 Catalog Number : NFII-300

Device Description : NuFix II Drill Guide Rev. 01

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NuFix II - B946NFII300IR0 Catalog Number : NFII-300

Device Description : NuFix II Drill Guide

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NuFix II - B946NFII4020 Catalog Number : NFII-402

Device Description : NuFix II Drill, 5.0mm Rev. 01

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

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