DePuy Synthes FDA Approvals

0 new drug approvals and 9 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
DePuy Synthes Retrograde Femoral Nail Advanced System510(k)Aug 1, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 1, 2024
Robotic Integration Instruments510(k)Jun 17, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jun 17, 2024
CROSSNAV Navigation Enabled Instruments510(k)Jun 17, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jun 17, 2024
TELIGEN System Navigation Ready Instruments510(k)Jun 14, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jun 14, 2024
DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System510(k)Mar 21, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 21, 2024
DEPUY SYNTHES MAXFRAME AUTOSTRUT System510(k)Jul 26, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jul 26, 2023
DePuy Synthes 3.5mm Intrapelvic Acetabular System510(k)Sep 20, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 20, 2022
DePuy Synthes Radial Head Replacement System510(k)Mar 18, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 18, 2022
DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)510(k)Jun 2, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 2, 2021