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 - B0751000120020 Catalog Number : DSCL-4050

Device Description : Crosslink

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B0751000120030 Catalog Number : DSCL-5065

Device Description : Crosslink

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B0751000120040 Catalog Number : DSCL-6580

Device Description : Crosslink

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B0751000200250 Catalog Number : DS-2025

Device Description : Straight Rod

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B0751000200300 Catalog Number : DS-2030

Device Description : Straight Rod

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B0751000200350 Catalog Number : DS-2035

Device Description : Straight Rod

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B0751000200400 Catalog Number : DS-2040

Device Description : Straight Rod

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B0751000200500 Catalog Number : DS-2050

Device Description : Straight Rod

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B0751000200600 Catalog Number : DS-2060

Device Description : Straight Rod

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B0751000200700 Catalog Number : DS-2070

Device Description : Straight Rod

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

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