meddevicedb.com FDA Device Reference

Tornier Pyrocarbon Humeral Head

DEN220012 Class II Post-NSE
Decision Date
2022-12-16
Sponsor / Applicant
Tornier S.A.S.

Technical Specification

510(k) Submission ID DEN220012
Product Code QKW
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3695
Decision Date 2022-12-16
Clearance Pathway Post-NSE

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

Tornier Pyrocarbon Humeral Head received FDA 510(k) clearance under submission number DEN220012, sponsored by Tornier S.A.S.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2022-12-16.

Classification & Regulation

This clearance is catalogued under FDA product code QKW and 21 CFR 888.3695, within the Orthopedic review panel as a Class II device.