BioPoly, LLC 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
BioPoly Radial Head Implant510(k)Mar 13, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 13, 2024
BioPoly Lesser Toe Hemiarthroplasty Implant510(k)Nov 22, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 22, 2022
BioPoly Great Toe Hemiarthroplasty Implant510(k)Feb 2, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 2, 2021