Medical Device Manufacturer · US , West Chester , PA

Synthes USA Products, LLC - FDA 510(k) Cleared Devices

60 submissions · 60 cleared · Since 2010
60
Total
60
Cleared
0
Denied
60 devices
26-50 of 60
Cleared Jan 18, 2017
Taps for Resorbable Screws
K153587 · HBG
Neurology · 399d
Cleared Nov 03, 2016
MatrixRIB Fixation System
K161590 · HRS
Orthopedic · 147d
Cleared Nov 01, 2016
T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System
K162358 · MAX
Orthopedic · 70d
Cleared Sep 26, 2016
DePuy Synthes TFNA Augmentation System
K160167 · HSB
Orthopedic · 243d
Cleared Aug 21, 2015
SYNFIX Evolution Secured Spacer System
K150673 · OVD
Orthopedic · 158d
Cleared Jun 23, 2015
Dental Bone Cutting Instruments
K150796 · DZJ
Dental · 89d
Cleared Jun 18, 2015
DePuy Synthes T-PAL Ti Spacer
K151276 · MAX
Orthopedic · 36d
Cleared May 28, 2015
Mandible External Fixator - MR Conditional
K143285 · MQN
Dental · 192d
Cleared Mar 23, 2015
Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates...
K150099 · HRS
Orthopedic · 62d
Cleared Jan 20, 2015
Synapse Occipital-Cervical-Thoracic (OCT) System
K142838 · NKG
Orthopedic · 112d
Cleared Oct 17, 2014
MATRIXWAVE MMF SYSTEM
K141165 · JEY
Dental · 164d
Cleared Sep 25, 2014
SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM
K141897 · KWP
Orthopedic · 73d
Cleared Aug 29, 2014
DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K141796 · HRS
Orthopedic · 57d
Cleared Aug 14, 2014
SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM
K130720 · KCT
General Hospital · 514d
Cleared Aug 07, 2014
MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM
K141241 · HRS
Orthopedic · 86d
Cleared Jun 13, 2014
MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)
K140462 · GWO
Neurology · 109d
Cleared May 02, 2014
MATRIXRIB FIXATION SYSTEM
K133616 · HRS
Orthopedic · 158d
Cleared Feb 28, 2014
SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM
K131548 · HSB
Orthopedic · 274d
Cleared Jan 16, 2014
SYNAPSE SYSTEM
K133698 · KWP
Orthopedic · 44d
Cleared Jan 06, 2014
LATERAL SYNFIX
K131276 · OVD
Orthopedic · 245d
Cleared Dec 16, 2013
DEPUY SYNTHES SPINE DENS ACCESS SYSTEM
K132910 · HWC
Orthopedic · 90d
Cleared Oct 08, 2013
SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM
K131186 · HRS
Orthopedic · 166d
Cleared May 24, 2013
SYNTHES SYNCAGE EVOLUTION SPACER
K122639 · MAX
Orthopedic · 268d
Cleared Jan 08, 2013
FALCON SPACER
K123180 · MAX
Orthopedic · 90d
Cleared Jul 06, 2012
SYNTHES MULTILOC HUMERAL NAILING SYSTEM
K120807 · HSB
Orthopedic · 112d
Filters