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

Bone Cement, Posterior Screw Augmentation (PML) (10) Thoracolumbosacral Pedicle Screw System (NKB) (10)

Premarket Exempt

Clear

CarboClear X Pedicle Screw System - 07290117350300 Catalog Number : PNNSC6550FN

Device Description : Fenestrated pedicle screw (oncology)

Device Class : 2

Duns Number: 649185170

Premarket Exempt : No

Product Code : PML, NKB

Prescription Use : Yes

Device Count : 1

CarboClear X Pedicle Screw System - 07290117350317 Catalog Number : PNNSC6555FN

Device Description : Fenestrated pedicle screw (oncology)

Device Class : 2

Duns Number: 649185170

Premarket Exempt : No

Product Code : PML, NKB

Prescription Use : Yes

Device Count : 1

CarboClear X Pedicle Screw System - 07290117350324 Catalog Number : PNNSC7535FN

Device Description : Fenestrated pedicle screw (oncology)

Device Class : 2

Duns Number: 649185170

Premarket Exempt : No

Product Code : PML, NKB

Prescription Use : Yes

Device Count : 1

CarboClear X Pedicle Screw System - 07290117350331 Catalog Number : PNNSC7540FN

Device Description : Fenestrated pedicle screw (oncology)

Device Class : 2

Duns Number: 649185170

Premarket Exempt : No

Product Code : PML, NKB

Prescription Use : Yes

Device Count : 1

CarboClear X Pedicle Screw System - 07290117350348 Catalog Number : PNNSC7545FN

Device Description : Fenestrated pedicle screw (oncology)

Device Class : 2

Duns Number: 649185170

Premarket Exempt : No

Product Code : PML, NKB

Prescription Use : Yes

Device Count : 1

CarboClear X Pedicle Screw System - 07290117350355 Catalog Number : PNNSC7550FN

Device Description : Fenestrated pedicle screw (oncology)

Device Class : 2

Duns Number: 649185170

Premarket Exempt : No

Product Code : PML, NKB

Prescription Use : Yes

Device Count : 1

CarboClear X Pedicle Screw System - 07290117350362 Catalog Number : PNNSC7555FN

Device Description : Fenestrated pedicle screw (oncology)

Device Class : 2

Duns Number: 649185170

Premarket Exempt : No

Product Code : PML, NKB

Prescription Use : Yes

Device Count : 1

CarboClear X Pedicle Screw System - 07290117350379 Catalog Number : PNNSC8540FN

Device Description : Fenestrated pedicle screw (oncology)

Device Class : 2

Duns Number: 649185170

Premarket Exempt : No

Product Code : NKB, PML

Prescription Use : Yes

Device Count : 1

CarboClear X Pedicle Screw System - 07290117350386 Catalog Number : PNNSC8545FN

Device Description : Fenestrated pedicle screw (oncology)

Device Class : 2

Duns Number: 649185170

Premarket Exempt : No

Product Code : NKB, PML

Prescription Use : Yes

Device Count : 1

CarboClear X Pedicle Screw System - 07290117350393 Catalog Number : PNNSC8550FN

Device Description : Fenestrated pedicle screw (oncology)

Device Class : 2

Duns Number: 649185170

Premarket Exempt : No

Product Code : NKB, PML

Prescription Use : Yes

Device Count : 1

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