Miach Orthopaedics, Inc. FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
BEAR® (Bridge-Enhanced ACL Restoration) Implant510(k)Jan 13, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 13, 2026
BEAR® (Bridge-Enhanced ACL Restoration) Implant510(k)Mar 6, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 6, 2025