meddevicedb.com FDA Device Reference

RemeOs™ Screw LAG Solid

DEN220030 Class II Direct
Decision Date
2023-03-29
Sponsor / Applicant
Bioretec, Ltd.

Technical Specification

510(k) Submission ID DEN220030
Product Code QJD
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3041
Decision Date 2023-03-29
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

RemeOs™ Screw LAG Solid received FDA 510(k) clearance under submission number DEN220030, sponsored by Bioretec, Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2023-03-29.

Classification & Regulation

This clearance is catalogued under FDA product code QJD and 21 CFR 888.3041, within the Orthopedic review panel as a Class II device.