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FDA 510(k)

CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant

K-Number: K251885 · 2025-07-10

ApplicantProvidence Medical Technology, Inc.
Decision Date2025-07-10
Product CodeMRW
DecisionSubstantially Equivalent

Device Summary

CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant is a medical device manufactured by Providence Medical Technology, Inc.. It received FDA 510(k) clearance on 2025-07-10 under approval number K251885. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant?

CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant is a medical device that received FDA 510(k) clearance on 2025-07-10. It is manufactured by Providence Medical Technology, Inc.. The 510(k) number is K251885.

When was CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant approved by the FDA?

CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant received FDA 510(k) clearance on 2025-07-10, under approval number K251885.

What company makes CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant?

CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant is manufactured by Providence Medical Technology, Inc..

What is the FDA product code for CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant?

The FDA product code for CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant is MRW.

Related Clinical Trials

NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING

Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Providence Medical Technology, Inc.

K161642CAVUX™ Cervical Cage K172279PMT Posterior Fixation System K170698ALLY(TM) Bone Screws K163474CAVUX CervicalCage-L SA System K163374ALLY™ Facet Screws K180876DTRAX Spinal System

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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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