Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices FDA Approvals

0 new drug approvals and 3 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
Valkyrie Thoracic Fixation System510(k)Dec 8, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 8, 2023
Valkyrie Thoracic Fixation System510(k)Jun 23, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jun 23, 2021
Able Medical Devices Valkyrie Thoracic Fixation System510(k)Mar 2, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 2, 2021