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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 the device name listed in this FDA 510(k) record. The listed applicant is Spineguard S.A.. It received FDA 510(k) clearance on 2022-03-31 under 510(k) 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. The listed applicant is Spineguard S.A.. The 510(k) number is K220160.

When did PediGuard Threaded receive FDA 510(k) clearance?

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

Who is the listed applicant for PediGuard Threaded?

The FDA 510(k) record lists Spineguard S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PediGuard Threaded?

The FDA product code for PediGuard Threaded is PDQ.

Other records listing Spineguard S.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201454DSG Connect TechnologyK162884SpineGuard DSG Zavation Screw SystemK152747DSG Threaded Drill System

Related Devices (Code: PDQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)NeuralytixK253580Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)Tedan Surgical InnovationsK243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLCK223438TELIGEN System Peripheral Motor Nerve Stimulation IndicationsMedos International SARLK221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.K203684Neurosign 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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