SPINAL BALANCE, INC.

Address:11360 S Airfield Road,Swanton,OH,43558,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, Spinal Pedicle Fixation, For Degenerative Disc Disease (NKB) (10) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (10)

Premarket Exempt

Clear

Libra Pedicle Screw System - 00841327102745 Catalog Number :

Device Description : Libra Screw Assembly, Polyaxial, 4.5mm x 25mm

Device Class : 2

Duns Number: 042418840

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Libra Pedicle Screw System - 00841327102752 Catalog Number :

Device Description : Libra Screw Assembly, Polyaxial, 4.5mm x 30mm

Device Class : 2

Duns Number: 042418840

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Libra Pedicle Screw System - 00841327102769 Catalog Number :

Device Description : Libra Screw Assembly, Polyaxial, 4.5mm x 35mm

Device Class : 2

Duns Number: 042418840

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Libra Pedicle Screw System - 00841327102776 Catalog Number :

Device Description : Libra Screw Assembly, Polyaxial, 4.5mm x 40mm

Device Class : 2

Duns Number: 042418840

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Libra Pedicle Screw System - 00841327102783 Catalog Number :

Device Description : Libra Screw Assembly, Polyaxial, 4.5mm x 45mm

Device Class : 2

Duns Number: 042418840

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Libra Pedicle Screw System - 00841327102790 Catalog Number :

Device Description : Libra Screw Assembly, Polyaxial, 4.5mm x 50mm

Device Class : 2

Duns Number: 042418840

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Libra Pedicle Screw System - 00841327103124 Catalog Number :

Device Description : Libra Screw Assembly, Polyaxial, 5.5mm x 30mm

Device Class : 2

Duns Number: 042418840

Premarket Exempt : No

Product Code : MNI, MNH, NKB

Prescription Use : Yes

Device Count : 1

Libra Pedicle Screw System - 00841327103131 Catalog Number :

Device Description : Libra Screw Assembly, Polyaxial, Cannulated, 5.5mm x 30mm

Device Class : 2

Duns Number: 042418840

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Libra Pedicle Screw System - 00841327103148 Catalog Number :

Device Description : Libra Screw Assembly, Polyaxial, 5.5mm x 35mm

Device Class : 2

Duns Number: 042418840

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Libra Pedicle Screw System - 00841327103155 Catalog Number :

Device Description : Libra Screw Assembly, Polyaxial, Cannulated, 5.5mm x 35mm

Device Class : 2

Duns Number: 042418840

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

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