Synthes (USA) Products, LLC FDA Approvals

0 new drug approvals and 5 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
MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System510(k)Jun 11, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 11, 2026
SyntheCel Dura Repair510(k)Jan 28, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jan 28, 2022
MAXFRAME Multi-Axial Correction System (aka MAXFRAME)510(k)May 25, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	May 25, 2021
DePuy Synthes Variable Angle Locking Patella Plating System510(k)Apr 8, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 8, 2021
DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System510(k)Mar 26, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 26, 2021