meddevicedb.com FDA Device Reference

Osteoboost Belt

DEN230015 Class II Direct
Decision Date
2024-01-12
Sponsor / Applicant
Bone Health Technologies, Inc.

Technical Specification

510(k) Submission ID DEN230015
Product Code QZO
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.5895
Decision Date 2024-01-12
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

Osteoboost Belt received FDA 510(k) clearance under submission number DEN230015, sponsored by Bone Health Technologies, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-01-12.

Classification & Regulation

This clearance is catalogued under FDA product code QZO and 21 CFR 888.5895, within the Orthopedic review panel as a Class II device.