meddevicedb.com FDA Device Reference

Stratum™ Reduced Size Foot Plating System

K200785 Class II Traditional
Decision Date
2020-07-27
Sponsor / Applicant
Nextremity Solutions, Inc.

Technical Specification

510(k) Submission ID K200785
Product Code HRS
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3030
Decision Date 2020-07-27
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Stratum™ Reduced Size Foot Plating System received FDA 510(k) clearance under submission number K200785, sponsored by Nextremity Solutions, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2020-07-27.

Classification & Regulation

This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.