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 - 00817329020400 Catalog Number : 80-4013/035

Device Description : 5.0mm Titanium Rod: 35mm Curved

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020417 Catalog Number : 80-4013/040

Device Description : 5.0mm Titanium Rod: 40mm Curved

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020424 Catalog Number : 80-4013/045

Device Description : 5.0mm Titanium Rod: 45mm Curved

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020431 Catalog Number : 80-4013/050

Device Description : 5.0mm Titanium Rod: 50mm Curved

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020448 Catalog Number : 80-4013/055

Device Description : 5.0mm Titanium Rod: 55mm Curved

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020455 Catalog Number : 80-4013/060

Device Description : 5.0mm Titanium Rod: 60mm Curved

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020462 Catalog Number : 80-4013/065

Device Description : 5.0mm Titanium Rod: 65mm Curved

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020479 Catalog Number : 80-4013/070

Device Description : 5.0mm Titanium Rod: 70mm Curved

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020486 Catalog Number : 80-4013/100

Device Description : 5.0mm Titanium Rod: 100mm Curved

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

CorticaLINK - 00817329020493 Catalog Number : 80-4014/5530

Device Description : Cancellous Screw: 5.5mm X 30mm

Device Class : 2

Duns Number: 067584601

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

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