Biomet Microfixation FDA Approvals

0 new drug approvals and 8 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
Pectus Blu System510(k)Jun 2, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 2, 2026
Pectus Blu Support Bar System510(k)Sep 19, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 19, 2024
2.1 x 255mm Drill, 22mm Stop510(k)Nov 15, 2022Neurology	Neurology	510(k)Substantially Equivalent (Special)	Nov 15, 2022
SternaLock Sternal Closure System510(k)May 17, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 17, 2022
RibFix Blu Thoracic Fixation System510(k)Apr 22, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 22, 2022
Pectus Support Bar System510(k)Mar 11, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 11, 2022
Twist Drills510(k)Dec 23, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Dec 23, 2021
Biomet Microfixation OmniMax MMF System510(k)Aug 5, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Aug 5, 2021