REPUBLIC SPINE

Address:2424 N Federal Hwy,Boca Raton,FL,33431,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

Orthosis, Spinal Pedicle Fixation (MNI) (10) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (10)

Premarket Exempt

Clear

Dark Star - B07510000875500 Catalog Number : DS-7550

Device Description : Polyaxial Screw

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B07510000875550 Catalog Number : DS-7555

Device Description : Polyaxial Screw

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B07510000885300 Catalog Number : DS-8530

Device Description : Polyaxial Screw

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B07510000885350 Catalog Number : DS-8535

Device Description : Polyaxial Screw

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B07510000885400 Catalog Number : DS-8540

Device Description : Polyaxial Screw

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B07510000885450 Catalog Number : DS-8545

Device Description : Polyaxial Screw

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B07510000885500 Catalog Number : DS-8550

Device Description : Polyaxial Screw

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B07510000885550 Catalog Number : DS-8555

Device Description : Polyaxial Screw

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B07510000885600 Catalog Number : DS-8560

Device Description : Polyaxial Screw

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B0751000120010 Catalog Number : DSCL-3540

Device Description : Crosslink

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

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