Medical Device Manufacturer · US , Washington , DC

Spineguard S.A.

6 submissions · 6 cleared · Since 2013
6
Total
6
Cleared
0
Denied

Spineguard S.A. — FDA 510(k) Submissions

Spineguard S.A. has submitted 6 FDA 510(k) premarket notifications since 2013, of which 6 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Neurosurgical Nerve Locator, Drills, Burrs, Trephines & Accessories (manual) . Use the specialty filter in the sidebar to narrow results.

6 devices
1–6 of 6
PediGuard Threaded
K220160 · PDQ Neurosurgical Nerve Locator · Neurology
Mar 2022 71d
DSG Connect Technology
K201454 · PDQ Neurosurgical Nerve Locator · Neurology
Feb 2021 254d
SpineGuard DSG Zavation Screw System
K162884 · HBG Drills, Burrs, Trephines... · Neurology
Jan 2017 90d
DSG Threaded Drill System
K152747 · PDQ Neurosurgical Nerve Locator · Neurology
Jun 2016 261d
Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip ?4.0mm, PediGuard Tri Tip ?3.2mm, PediGuard Tri Tip ?2.5mm, PediGuard ?2.5mm XS, PediGuard Curv, PediGuard Curv XS
K143159 · PDQ Neurosurgical Nerve Locator · Neurology
Jan 2015 81d
PEDIGUARD NERVE DETECTOR SYSTEM
K123390 · PDQ Neurosurgical Nerve Locator · Neurology
Aug 2013 279d
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