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, For Degenerative Disc Disease (NKB) (10) Orthosis, Spinal Pedicle Fixation (MNI) (9) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (9)

Premarket Exempt

Clear

Libra Pedicle Screw System - 00841327103896 Catalog Number :

Device Description : Libra Screw Assembly, Polyaxial, Cannulated, 6.5mm 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 - 00841327103902 Catalog Number :

Device Description : Libra Screw Assembly, Polyaxial, 6.5mm x 55mm

Device Class : 2

Duns Number: 042418840

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Libra Pedicle Screw System - 00841327103919 Catalog Number :

Device Description : Libra Screw Assembly, Polyaxial, Cannulated, 6.5mm x 55mm

Device Class : 2

Duns Number: 042418840

Premarket Exempt : No

Product Code : MNI, MNH, NKB

Prescription Use : Yes

Device Count : 1

Libra Pedicle Screw System - 00841327103926 Catalog Number :

Device Description : Libra Screw Assembly, Polyaxial, 6.5mm x 60mm

Device Class : 2

Duns Number: 042418840

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Libra Pedicle Screw System - 00841327103933 Catalog Number :

Device Description : Libra Screw Assembly, Polyaxial, Cannulated, 6.5mm x 60mm

Device Class : 2

Duns Number: 042418840

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Libra Pedicle Screw System - 00841327104480 Catalog Number :

Device Description : Libra Screw Assembly, Polyaxial, 7.5mm 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 - 00841327104497 Catalog Number :

Device Description : Libra Screw Assembly, Polyaxial, Cannulated, 7.5mm 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 - 00841327104503 Catalog Number :

Device Description : Libra Screw Assembly, Polyaxial, 7.5mm 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 - 00841327104510 Catalog Number :

Device Description : Libra Screw Assembly, Polyaxial, cannulated, 7.5mm 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 - 00841327104527 Catalog Number :

Device Description : Libra Screw Assembly, Polyaxial, 7.5mm x 40mm

Device Class : 2

Duns Number: 042418840

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

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