INNOVATIVE SURGICAL DESIGNS

Address:3903 S Walnut St,Bloomington,IN,47401,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

Thoracolumbosacral Pedicle Screw System (NKB) (8) Orthosis, Spinal Pedicle Fixation (MNI) (2) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (2)

Premarket Exempt

Clear

True Spinal Fixation System - B5061059302A8401 Catalog Number :

Device Description : 8.0mm x 40mm Extended Reduction Revision Polyaxial Pedicle Screw

Device Class : 2

Duns Number: 078306079

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

True Spinal Fixation System - B5061059302A8451 Catalog Number :

Device Description : 8.0mm x 45mm Extended Reduction Revision Polyaxial Pedicle Screw

Device Class : 2

Duns Number: 078306079

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

True Spinal Fixation System - B5061059302A8501 Catalog Number :

Device Description : 8.0mm x 50mm Extended Reduction Revision Polyaxial Pedicle Screw

Device Class : 2

Duns Number: 078306079

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

True Spinal Fixation System - B5061059302A9351 Catalog Number :

Device Description : 9.0mm x 35mm Extended Reduction Revision Polyaxial Pedicle Screw

Device Class : 2

Duns Number: 078306079

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

True Spinal Fixation System - B5061059302A9401 Catalog Number :

Device Description : 9.0mm x 40mm Extended Reduction Revision Polyaxial Pedicle Screw

Device Class : 2

Duns Number: 078306079

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

True Spinal Fixation System - B5061059302A9451 Catalog Number :

Device Description : 9.0mm x 45mm Extended Reduction Revision Polyaxial Pedicle Screw

Device Class : 2

Duns Number: 078306079

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

True Spinal Fixation System - B5061059302A9501 Catalog Number :

Device Description : 9.0mm x 50mm Extended Reduction Revision Polyaxial Pedicle Screw

Device Class : 2

Duns Number: 078306079

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

True Spinal Fixation System - B50610593051 Catalog Number :

Device Description : Instrument Kit

Device Class : 2

Duns Number: 078306079

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

True Spinal Fixation System - B50610593072 Catalog Number :

Device Description : Rod Benders

Device Class : 2

Duns Number: 078306079

Premarket Exempt : No

Product Code : MNH, MNI

Prescription Use : Yes

Device Count : 1

True Spinal Fixation System - B5061059307SR51 Catalog Number :

Device Description : 5.5mm Rod Bending Irons

Device Class : 2

Duns Number: 078306079

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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