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 - 00843672100506 Catalog Number :

Device Description : Polyax def screw 6.5x50mm for 5.5 rod

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : NKB, KWP

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672100513 Catalog Number :

Device Description : Polyax def screw 7.5x30mm for 5.5 rod

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672100520 Catalog Number :

Device Description : Polyax def screw 7.5x35mm for 5.5 rod

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : NKB, KWP

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672100537 Catalog Number :

Device Description : Polyax def screw 7.5x40mm for 5.5 rod

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672100544 Catalog Number :

Device Description : Polyax def screw 7.5x45mm for 5.5 rod

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : NKB, KWP

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672100551 Catalog Number :

Device Description : Polyax def screw 7.5x50mm for 5.5 rod

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672100568 Catalog Number :

Device Description : Polyax def screw 7.5x55mm for 5.5 rod

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : NKB, KWP

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672100575 Catalog Number :

Device Description : Iliac screw 7.5x50mm 0 deg

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672100582 Catalog Number :

Device Description : Iliac screw 7.5x60mm 0 deg

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : NKB, KWP

Prescription Use : Yes

Device Count : 1

INGENIX - 00843672100599 Catalog Number :

Device Description : Iliac screw 7.5x70mm 0 deg

Device Class : 2

Duns Number: 082805471

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

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