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FDA 510(k)

Ion Facet Screw System

K-Number: K211855 · 2022-02-25

ApplicantSurGenTec, LLC
Decision Date2022-02-25
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

Ion Facet Screw System is a medical device manufactured by SurGenTec, LLC. It received FDA 510(k) clearance on 2022-02-25 under approval number K211855. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ion Facet Screw System?

Ion Facet Screw System is a medical device that received FDA 510(k) clearance on 2022-02-25. It is manufactured by SurGenTec, LLC. The 510(k) number is K211855.

When was Ion Facet Screw System approved by the FDA?

Ion Facet Screw System received FDA 510(k) clearance on 2022-02-25, under approval number K211855.

What company makes Ion Facet Screw System?

Ion Facet Screw System is manufactured by SurGenTec, LLC.

What is the FDA product code for Ion Facet Screw System?

The FDA product code for Ion Facet Screw System is MRW.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes 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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Related Devices (Code: MRW)

K161798FacetBRIDGE® SystemLdr Spine USA, Inc. K152137FacetBRIDGE SystemLdr Spine USA K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc. K180729FaSet Fixation SystemHuvexel Co. , Ltd. K173198Facet Screw Fixation SystemU&I Corporation K192744CORRIDOR Fixation SystemGlobus Medical, Inc.

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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