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 - 00843672101510 Catalog Number :

Device Description : Tap for 5.5mm Screw

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672101527 Catalog Number :

Device Description : Tap for 6.0mm Screw

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672101534 Catalog Number :

Device Description : Tap for 7.0mm Screw

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672101541 Catalog Number :

Device Description : Tap for 6.5mm Screw

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : NKB, KWP

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672101558 Catalog Number :

Device Description : Tap for 7.5mm Screw

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : NKB, KWP

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672101565 Catalog Number :

Device Description : Rod Approximator

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672101572 Catalog Number :

Device Description : Hook Approximator 6.0mm Rod

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672101589 Catalog Number :

Device Description : Hook Approximator 5.0 Rod

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : NKB, KWP

Prescription Use : Yes

Device Count : 1

Ingenix - 00843672101596 Catalog Number :

Device Description : Polyax DEF Screw 7.5x60mm for 5.5mm Rod

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : NKB, KWP

Prescription Use : No

Device Count : 1

Ingenix - 00843672101602 Catalog Number :

Device Description : Polyax def screw 7.5x65mm for 5.5 rod

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : NKB, KWP

Prescription Use : Yes

Device Count : 1

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