meddevicedb.com FDA Device Reference

CORUS-LX Implant

K253190 Traditional
Decision Date
2025-11-20
Sponsor / Applicant
Providence Medical Technology, Inc.

Technical Specification

510(k) Submission ID K253190
Product Code MRW
Medical Specialty / Panel Unknown
Decision Date 2025-11-20
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

CORUS-LX Implant received FDA 510(k) clearance under submission number K253190, sponsored by Providence Medical Technology, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2025-11-20.

Classification & Regulation

This clearance is catalogued under FDA product code MRW , within the Unknown review panel as a device.