SPINAL RESOURCES, INC.

Address:5975 North Federal Highway,Fort Lauderdale,FL,33308,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) Pin, Fixation, Smooth (HTY) (2)

Premarket Exempt

Clear

Swedge Pedicle Screw Fixation System - B51521510 Catalog Number :

Device Description : MIS Tower Adjuster

Device Class : 2

Duns Number: 018255727

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Swedge Pedicle Screw Fixation System - B51522000 Catalog Number :

Device Description : Implant Case Assembly - Standard

Device Class : 2

Duns Number: 018255727

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Swedge Pedicle Screw Fixation System - B5152200M0 Catalog Number :

Device Description : Implant Case Assembly - MIS

Device Class : 2

Duns Number: 018255727

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Swedge Pedicle Screw Fixation System - B51522010 Catalog Number :

Device Description : Polyscrew System Case Assembly - Open/STD Instruments

Device Class : 2

Duns Number: 018255727

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Swedge Pedicle Screw Fixation System - B51522020 Catalog Number :

Device Description : Polyscrew System Case Assembly - MIS Instruments

Device Class : 2

Duns Number: 018255727

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Swedge Pedicle Screw Fixation System - B515LC010 Catalog Number :

Device Description : Locking Cap (Set Screw) - Spring Swivel

Device Class : 2

Duns Number: 018255727

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Swedge Pedicle Screw Fixation System - B515LC030 Catalog Number :

Device Description : Locking Cap T25

Device Class : 2

Duns Number: 018255727

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Swedge Pedicle Screw Fixation System - B515LC040 Catalog Number :

Device Description : Locking Cap Assy - Spring Swivel

Device Class : 2

Duns Number: 018255727

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

S-Wire - B515NDRS165000 Catalog Number :

Device Description : K-Wire, Double-Round Smooth, 1.6 x 500 mm (Nitinol)

Device Class : 2

Duns Number: 018255727

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

S-Wire - B515NSTS165000 Catalog Number :

Device Description : K-Wire, Single-Trocar, Round Smooth, 1.6 x 500 mm (Nitinol)

Device Class : 2

Duns Number: 018255727

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

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