meddevicedb.com FDA Device Reference

BEAR (Bridge-Enhanced ACL Repair) Implant

DEN200035 Class II Direct
Decision Date
2020-12-16
Sponsor / Applicant
Miach Orthopaedics, Inc.

Technical Specification

510(k) Submission ID DEN200035
Product Code QNI
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3044
Decision Date 2020-12-16
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

BEAR (Bridge-Enhanced ACL Repair) Implant received FDA 510(k) clearance under submission number DEN200035, sponsored by Miach Orthopaedics, 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 2020-12-16.

Classification & Regulation

This clearance is catalogued under FDA product code QNI and 21 CFR 888.3044, within the Orthopedic review panel as a Class II device.