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) (10)

Premarket Exempt

Clear

Swedge Pedicle Screw Fixation System - B51521210 Catalog Number :

Device Description : Rod Pusher, MIS

Device Class : 2

Duns Number: 018255727

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Swedge Pedicle Screw Fixation System - B51521240 Catalog Number :

Device Description : Rod Rocker, Standard, Ti Tulip

Device Class : 2

Duns Number: 018255727

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Swedge Pedicle Screw Fixation System - B51521250 Catalog Number :

Device Description : Rod Rocker, Small, Co-Cr Tulip

Device Class : 2

Duns Number: 018255727

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Swedge Pedicle Screw Fixation System - B5152126010 Catalog Number :

Device Description : Rod Rocker, Forceps, Large (Ti Tulip)

Device Class : 2

Duns Number: 018255727

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Swedge Pedicle Screw Fixation System - B5152126020 Catalog Number :

Device Description : Rod Rocker, Forceps, Small (Co-Cr Tulip)

Device Class : 2

Duns Number: 018255727

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Swedge Pedicle Screw Fixation System - B51521270 Catalog Number :

Device Description : Curved Ratchet Handle, 1/4-Square Style, Cannulated

Device Class : 2

Duns Number: 018255727

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Swedge Pedicle Screw Fixation System - B51521280 Catalog Number :

Device Description : T-Handle, Ratchet, 1/4-Square Style, Cannulated

Device Class : 2

Duns Number: 018255727

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Swedge Pedicle Screw Fixation System - B51521290 Catalog Number :

Device Description : T-Handle, Non-Ratchet, 1/4-Square Style, Cannulated

Device Class : 2

Duns Number: 018255727

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Swedge Pedicle Screw Fixation System - B51521300 Catalog Number :

Device Description : Torque Limiter, Extended T-Handle, 100 in-lbs, 1/4-Square Style

Device Class : 2

Duns Number: 018255727

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Swedge Pedicle Screw Fixation System - B51521310 Catalog Number :

Device Description : Counter-Torque Wrench, Standard

Device Class : 2

Duns Number: 018255727

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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