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 - B07510000555500 Catalog Number : DSR-5550

Device Description : Reduction Screw

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B07510000565300 Catalog Number : DSR-6530

Device Description : Reduction Screw

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B07510000565350 Catalog Number : DSR-6535

Device Description : Reduction Screw

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B07510000565400 Catalog Number : DSR-6540

Device Description : Reduction Screw

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B07510000565450 Catalog Number : DSR-6545

Device Description : Reduction Screw

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B07510000565500 Catalog Number : DSR-6550

Device Description : Reduction Screw

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B07510000565550 Catalog Number : DSR-6555

Device Description : Reduction Screw

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B07510000575300 Catalog Number : DSR-7530

Device Description : Reduction Screw

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B07510000575350 Catalog Number : DSR-7535

Device Description : Reduction Screw

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B07510000575400 Catalog Number : DSR-7540

Device Description : Reduction Screw

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

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