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 - B0751000800500 Catalog Number : DS-1050

Device Description : Pre-bent Rod

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B0751000800600 Catalog Number : DS-1060

Device Description : Pre-bent Rod

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B0751000800700 Catalog Number : DS-1070

Device Description : Pre-bent Rod

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B0751000800800 Catalog Number : DS-1080

Device Description : Pre-bent Rod

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B0751000800900 Catalog Number : DS-1090

Device Description : Pre-bent Rod

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B0751000801000 Catalog Number : DS-1100

Device Description : Pre-bent Rod

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B0751000801100 Catalog Number : DS-1110

Device Description : Pre-bent Rod

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B0751000801200 Catalog Number : DS-1120

Device Description : Pre-bent Rod

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

Dark Star - B0751000801300 Catalog Number : DS-1130

Device Description : Pre-bent Rod

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNI, MNH

Prescription Use : Yes

Device Count : 1

Dark Star - B0751000801400 Catalog Number : DS-1140

Device Description : Pre-bent Rod

Device Class : 2

Duns Number: 061891717

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

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