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) Orthosis, Spinal Pedicle Fixation (MNI) (5) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (5) Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (OSH) (5) Thoracolumbosacral Pedicle Screw System (NKB) (5)

Premarket Exempt

Clear

EZ-Track - 00840314100429 Catalog Number : CAAB220907F

Device Description : PLIF 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 - 00840314100436 Catalog Number : CAAB220908F

Device Description : PLIF INTERBODY CAGE, 9 X 22 X 8MM -5°

Device Class : 2

Duns Number: 046767258

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EZ-Track - 00840314100443 Catalog Number : CAAB220909F

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

Device Class : 2

Duns Number: 046767258

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EZ-Track - 00840314101389 Catalog Number : CABB220907A

Device Description : OTLIF INTERBODY CAGE, 9 X 22 X 7MM -0°

Device Class : 2

Duns Number: 046767258

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EZ-Track - 00840314102829 Catalog Number : CACB240907F

Device Description : TLIF INTERBODY CAGE, 9 X 24 X 7MM -5°

Device Class : 2

Duns Number: 046767258

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Nex-D2 - 00840314107848 Catalog Number : CBAJJ-40045

Device Description : UNIPLANAR SCREW, 4.0MM X 45MM

Device Class : 2

Duns Number: 046767258

Premarket Exempt : No

Product Code : NKB, OSH, MNI, MNH

Prescription Use : Yes

Device Count : 1

Nex-D2 - 00840314111814 Catalog Number :

Device Description : POLYAXIAL SCREW, 4.0MM X 40MM

Device Class : 2

Duns Number: 046767258

Premarket Exempt : No

Product Code : NKB, OSH, MNI, MNH

Prescription Use : Yes

Device Count : 1

Nex-D2 - 00840314113085 Catalog Number : CBACJ-40030

Device Description : HIGH TOP POLYAXIAL SCREW, 4.0MM X 30MM

Device Class : 2

Duns Number: 046767258

Premarket Exempt : No

Product Code : NKB, OSH, MNI, MNH

Prescription Use : Yes

Device Count : 1

Nex-D2 - 00840314114310 Catalog Number : CBAEJ-40020

Device Description : FIXED 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 - 00840314115560 Catalog Number : CBBAJ-50020

Device Description : CANNULATED POLYAXIAL SCREW, 5.0MM X 20MM

Device Class : 2

Duns Number: 046767258

Premarket Exempt : No

Product Code : NKB, OSH, MNI, MNH

Prescription Use : Yes

Device Count : 1

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