NEXT ORTHOSURGICAL, INC.

Address:3270 Corporate Vw Ste A,Vista,CA,92081,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

Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (5) Thoracolumbosacral Pedicle Screw System (NKB) (4) Orthosis, Spinal Pedicle Fixation (MNI) (3) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (3) Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (OSH) (3) Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (1)

Premarket Exempt

Clear

Nex-D2 - 00840314116567 Catalog Number : CBCAJ-00000

Device Description : SET SCREW, T-30 HEXALOBE

Device Class : 2

Duns Number: 046767258

Premarket Exempt : No

Product Code : NKB, OSH, MNI, MNH

Prescription Use : Yes

Device Count : 1

Nex-D2 - 00840314116574 Catalog Number : CBCBJ-00000

Device Description : SET SCREW, CANNULATED, T-30 HEXALOBE

Device Class : 2

Duns Number: 046767258

Premarket Exempt : No

Product Code : NKB, OSH, MNI, MNH

Prescription Use : Yes

Device Count : 1

EZ-Track - 00840314122186 Catalog Number : CAAB300907F

Device Description : PLIF INTERBODY CAGE, 9 X 30 X 7MM -5°

Device Class : 2

Duns Number: 046767258

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EZ-Track - 00840314122506 Catalog Number : CABB200907A

Device Description : OTLIF INTERBODY CAGE, 9 X 20 X 7MM -0°

Device Class : 2

Duns Number: 046767258

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EZ-Track - 00840314122988 Catalog Number : CACB220907F

Device Description : TLIF INTERBODY CAGE, 9 X 22 X 7MM -5°

Device Class : 2

Duns Number: 046767258

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EZ-Track - 00840314128027 Catalog Number : CAFB401808A

Device Description : LLIF INTERBODY CAGE, 18 X 40 X 8MM -0°

Device Class : 2

Duns Number: 046767258

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EZ-Track - 00840314134561 Catalog Number : CAEB243010A

Device Description : ALIF INTERBODY CAGE, 30 X 24 X 10MM -0°

Device Class : 2

Duns Number: 046767258

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EZ-Track - 00840314136909 Catalog Number : CJAB141205A

Device Description : CERVICAL CAGE, FLAT, 14 X 12 X 5MM -0°

Device Class : 2

Duns Number: 046767258

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

Nex-D2 - 00840314139115 Catalog Number : CBAMJ-40020

Device Description : HIGH TOP UNIPLANAR SCREW, 4.0MM X 20MM

Device Class : 2

Duns Number: 046767258

Premarket Exempt : No

Product Code : NKB, OSH, MNI, MNH

Prescription Use : Yes

Device Count : 1

Nex-D2 - 00840314155467 Catalog Number : CBAPJ-80030

Device Description : POLYAXIAL SCREW, LARGE OD, 8.0MM X 30MM

Device Class : 2

Duns Number: 046767258

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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