LINKSPINE, INC.

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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

Yes No

Clear

CorticaLINK - 00817329020103 Catalog Number : 80-4003/030

Device Description : 5.0mm Titanium Rod: 30mm Straight

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020110 Catalog Number : 80-4003/035

Device Description : 5.0mm Titanium Rod: 35mm Straight

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020127 Catalog Number : 80-4003/040

Device Description : 5.0mm Titanium Rod: 40mm Straight

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020134 Catalog Number : 80-4003/050

Device Description : 5.0mm Titanium Rod: 50mm Straight

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020141 Catalog Number : 80-4003/060

Device Description : 5.0mm Titanium Rod: 60mm Straight

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020158 Catalog Number : 80-4003/070

Device Description : 5.0mm Titanium Rod: 70mm Straight

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020165 Catalog Number : 80-4003/100

Device Description : 5.0mm Titanium Rod: 100mm Straight

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020172 Catalog Number : 80-4006/4525

Device Description : Cortical Screw: 4.5mm X 25mm

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020189 Catalog Number : 80-4006/4530

Device Description : Cortical Screw: 4.5mm X 30mm

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020196 Catalog Number : 80-4006/4535

Device Description : Cortical Screw: 4.5mm X 35mm

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

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