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) (5)

Premarket Exempt

Yes

Clear

NuFix II - B946NFII5000 Catalog Number : NFII-500

Device Description : NuFix II Inserter Rev. 01

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NuFix II - B946NFII500IR0 Catalog Number : NFII-500

Device Description : NuFix II Inserter

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NuFix II - B946NFII6000 Catalog Number : NFII-600

Device Description : NuFix II Non-Cannulated Blade

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NuFix II - B946NFII600C0 Catalog Number : NFII-600C

Device Description : NuFix II Cannulated Blade Rev. 01

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

NuFix II - B946NFII600CIR0 Catalog Number : NFII-600C

Device Description : NuFix II Cannulated Blade

Device Class : 1

Duns Number: 080867996

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

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