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 - B07510023585550 Catalog Number : DSCT-8555

Device Description : Cannulated Polyaxial Reduction Screw

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B0751002510 Catalog Number : DS0022

Device Description : BoneAwl

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B0751002580 Catalog Number : DS0008

Device Description : Ratcheting Straight Handle

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B0751002590 Catalog Number : DS0009

Device Description : Ratcheting T Handle

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B0751002600 Catalog Number : DS0001

Device Description : Polyaxial Screwdriver

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B0751002610 Catalog Number : DS0016

Device Description : French Rod Bender

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B0751002630 Catalog Number : DS0014-H

Device Description : Rod Gripper Power grip

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B0751002640 Catalog Number : DS0012

Device Description : Rod Pusher

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B0751002670 Catalog Number : DS0011

Device Description : Rod Gripper Forceps

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B0751002680 Catalog Number : DS0004

Device Description : Set Screw Inserter

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

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