INGENIUMSPINE, LLC

Address:1255 W Rio Salado Parkway #107,Tempe,AZ,85281,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

Appliance, Fixation, Spinal Interlaminal (KWP) (10) Thoracolumbosacral Pedicle Screw System (NKB) (10)

Premarket Exempt

Clear

INGENIX - 00843672101312 Catalog Number :

Device Description : Smooth rod 6x40mm

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : NKB, KWP

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672101329 Catalog Number :

Device Description : Smooth rod 6x50mm

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672101336 Catalog Number :

Device Description : Smooth rod 6x60mm

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : NKB, KWP

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672101343 Catalog Number :

Device Description : Smooth rod 6x70mm

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672101350 Catalog Number :

Device Description : Smooth rod 6x80mm

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : NKB, KWP

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672101367 Catalog Number :

Device Description : Smooth rod 6x90mm

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672101374 Catalog Number :

Device Description : Smooth rod 6x100mm

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : NKB, KWP

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672101381 Catalog Number :

Device Description : Smooth rod 6x120mm

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672101398 Catalog Number :

Device Description : Smooth rod 6x150mm

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : NKB, KWP

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672101404 Catalog Number :

Device Description : Smooth rod 6x180mm

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

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