meddevicedb.com FDA Device Reference

OsteoProbe

DEN210013 Class II Direct
Decision Date
2021-08-19
Sponsor / Applicant
Active Life Scientific, Inc.

Technical Specification

510(k) Submission ID DEN210013
Product Code QGQ
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.1600
Decision Date 2021-08-19
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

OsteoProbe received FDA 510(k) clearance under submission number DEN210013, sponsored by Active Life Scientific, 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 2021-08-19.

Classification & Regulation

This clearance is catalogued under FDA product code QGQ and 21 CFR 888.1600, within the Orthopedic review panel as a Class II device.