meddevicedb.com FDA Device Reference

ReneuRx™ (Neural Ice)

DEN250067 Class II Direct
Decision Date
2026-08-21
Sponsor / Applicant
Brixton Biosciences

Technical Specification

510(k) Submission ID DEN250067
Product Code SJA
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3048
Decision Date 2026-08-21
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

ReneuRx™ (Neural Ice) received FDA 510(k) clearance under submission number DEN250067, sponsored by Brixton Biosciences. The device was reviewed via the Direct premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2026-08-21.

Classification & Regulation

This clearance is catalogued under FDA product code SJA and 21 CFR 888.3048, within the Orthopedic review panel as a Class II device.