Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DSG Threaded Drill System

K-Number: K152747 · 2016-06-10

ApplicantSpineguard S.A.
Decision Date2016-06-10
Product CodePDQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DSG Threaded Drill System 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 2016-06-10 under 510(k) number K152747. 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 DSG Threaded Drill System?

DSG Threaded Drill System is a medical device that received FDA 510(k) clearance on 2016-06-10. The listed applicant is Spineguard S.A.. The 510(k) number is K152747.

When did DSG Threaded Drill System receive FDA 510(k) clearance?

DSG Threaded Drill System received FDA 510(k) clearance on 2016-06-10, under 510(k) number K152747.

Who is the listed applicant for DSG Threaded Drill System?

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 DSG Threaded Drill System?

The FDA product code for DSG Threaded Drill System 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.

K220160PediGuard ThreadedK201454DSG Connect TechnologyK162884SpineGuard DSG Zavation Screw 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.K220160PediGuard ThreadedSpineguard S.A.

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.

↑