Nextremity Solutions, Inc. FDA Approvals

0 new drug approvals and 7 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
Nextra CH Cannulated Hammertoe System510(k)Nov 4, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 4, 2022
CalcShift Displacement Calcaneal Osteotomy System510(k)May 20, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 20, 2022
StealthFix Intraosseous Fixation System510(k)Mar 22, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 22, 2022
InCore Subtalar System510(k)Dec 21, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 21, 2021
Nextra CH Cannulated Hammertoe System510(k)Dec 9, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Dec 9, 2021
Stratum® Ankle Fusion Plating System510(k)Nov 18, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 18, 2021
Nexta PEEK Hammertoe Correction System510(k)Sep 23, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 23, 2021