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

No Yes

Clear

CorticaLINK - 00817329020004 Catalog Number : 80-4001

Device Description : Locking Cap

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020011 Catalog Number : 80-4002/025

Device Description : 5.0mm CoCr Rod: 25mm Straight

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020028 Catalog Number : 80-4002/030

Device Description : 5.0mm CoCr Rod: 30mm Straight

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020035 Catalog Number : 80-4002/035

Device Description : 5.0mm CoCr Rod: 35mm Straight

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020042 Catalog Number : 80-4002/040

Device Description : 5.0mm CoCr Rod: 40mm Straight

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020059 Catalog Number : 80-4002/050

Device Description : 5.0mm CoCr Rod: 50mm Straight

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020066 Catalog Number : 80-4002/060

Device Description : 5.0mm CoCr Rod: 60mm Straight

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020073 Catalog Number : 80-4002/070

Device Description : 5.0mm CoCr Rod: 70mm Straight

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020080 Catalog Number : 80-4002/100

Device Description : 5.0mm CoCr Rod: 100mm Straight

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020097 Catalog Number : 80-4003/025

Device Description : 5.0mm Titanium Rod: 25mm Straight

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

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