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

FDA 510(k)

FFX Facet Fixation System

K-Number: K252153 · 2025-10-16

ApplicantSc Medica
Decision Date2025-10-16
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

FFX Facet Fixation System is a medical device manufactured by Sc Medica. It received FDA 510(k) clearance on 2025-10-16 under approval number K252153. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FFX Facet Fixation System?

FFX Facet Fixation System is a medical device that received FDA 510(k) clearance on 2025-10-16. It is manufactured by Sc Medica. The 510(k) number is K252153.

When was FFX Facet Fixation System approved by the FDA?

FFX Facet Fixation System received FDA 510(k) clearance on 2025-10-16, under approval number K252153.

What company makes FFX Facet Fixation System?

FFX Facet Fixation System is manufactured by Sc Medica.

What is the FDA product code for FFX Facet Fixation System?

The FDA product code for FFX Facet Fixation System is MRW.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT06720948 The ION Facet Screw System Ambispective Evaluation ENROLLING_BY_INVITATION

Other Devices by Sc Medica

K232468SC Medica FFX K250679FFX Facet Fixation System

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.

↑