CARBOFIX ORTHOPEDICS LTD

Address:11 HAHOSHLIM ST.,Herzeliya Central,IL

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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

Thoracolumbosacral Pedicle Screw System (NKB) (7) Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (2) Spinal Vertebral Body Replacement Device (MQP) (1)

Premarket Exempt

Clear

CarboClear Lumbar Cage System - 07290110208837 Catalog Number : CCLC271405

Device Description : A lumbar intervertebral body fusion device

Device Class : 2

Duns Number: 649185170

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

CarboClear Lumbar Cage System - 07290110208844 Catalog Number : CCLC271410

Device Description : A lumbar intervertebral body fusion device

Device Class : 2

Duns Number: 649185170

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

CarboClear X Pedicle Screw System - 07290110209780 Catalog Number : PNNS5020N

Device Description : Non-cannulated pedicle screw

Device Class : 2

Duns Number: 649185170

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

CarboClear X Pedicle Screw System - 07290110209797 Catalog Number : PNNS5025N

Device Description : Non-cannulated pedicle screw

Device Class : 2

Duns Number: 649185170

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

CarboClear X Pedicle Screw System - 07290110209803 Catalog Number : PNNS5030N

Device Description : Non-cannulated pedicle screw

Device Class : 2

Duns Number: 649185170

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

CarboClear X Pedicle Screw System - 07290110209810 Catalog Number : PNNS5035N

Device Description : Non-cannulated pedicle screw

Device Class : 2

Duns Number: 649185170

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

CarboClear X Pedicle Screw System - 07290110209827 Catalog Number : PNNS5040N

Device Description : Non-cannulated pedicle screw

Device Class : 2

Duns Number: 649185170

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

CarboClear X Pedicle Screw System - 07290110209834 Catalog Number : PNNS5045N

Device Description : Non-cannulated pedicle screw

Device Class : 2

Duns Number: 649185170

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

CarboClear Vertebral Body Replacement System - 07290110209841 Catalog Number : SP0011

Device Description : Patient-Specific spinal vertebral body replacement device

Device Class : 2

Duns Number: 649185170

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

CarboClear X Pedicle Screw System - 07290110209872 Catalog Number : PNNSC8540N

Device Description : Cannulated pedicle screw

Device Class :

Duns Number: 649185170

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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