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FDA 510(k)

Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover

K-Number: K152342 · 2016-06-09

ApplicantSt Jude Medical
Decision Date2016-06-09
Product CodeGXR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover is a medical device manufactured by St Jude Medical. It received FDA 510(k) clearance on 2016-06-09 under approval number K152342. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover?

Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover is a medical device that received FDA 510(k) clearance on 2016-06-09. It is manufactured by St Jude Medical. The 510(k) number is K152342.

When was Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover approved by the FDA?

Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover received FDA 510(k) clearance on 2016-06-09, under approval number K152342.

What company makes Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover?

Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover is manufactured by St Jude Medical.

What is the FDA product code for Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover?

The FDA product code for Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover is GXR.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT06720948 The ION Facet Screw System Ambispective Evaluation ENROLLING_BY_INVITATION NCT06960018 Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement RECRUITING

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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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