Response Ortho Solutions, LLC 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
The Response Ortho Smart Fixator - Hexapod System510(k)Nov 20, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 20, 2025
Response Ortho Metaphyseal Hinge Fixator System510(k)Sep 18, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 18, 2024