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FDA 510(k)

PediGuard Threaded

K-Number: K220160 · 2022-03-31

ApplicantSpineguard S.A.
Decision Date2022-03-31
Product CodePDQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PediGuard Threaded is a medical device manufactured by Spineguard S.A.. It received FDA 510(k) clearance on 2022-03-31 under approval number K220160. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PediGuard Threaded?

PediGuard Threaded is a medical device that received FDA 510(k) clearance on 2022-03-31. It is manufactured by Spineguard S.A.. The 510(k) number is K220160.

When was PediGuard Threaded approved by the FDA?

PediGuard Threaded received FDA 510(k) clearance on 2022-03-31, under approval number K220160.

What company makes PediGuard Threaded?

PediGuard Threaded is manufactured by Spineguard S.A..

What is the FDA product code for PediGuard Threaded?

The FDA product code for PediGuard Threaded is PDQ.

Other Devices by Spineguard S.A.

K152747DSG Threaded Drill System K162884SpineGuard DSG Zavation Screw System K201454DSG Connect Technology

Related Devices (Code: PDQ)

K161893Neuromonitoring KitSI-BONE, Inc. K152747DSG Threaded Drill SystemSpineguard S.A. K152942NuVasiveNVM5 SystemNu Vasive, Incorporated K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation K162313NuVasive Next Generation NVM5 SystemNu Vasive, Incorporated K181559Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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