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
44 devices
26-44 of 44
Cleared Aug 29, 2014
DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K141796 · HRS
Orthopedic · 57d
Cleared Aug 07, 2014
MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM
K141241 · HRS
Orthopedic · 86d
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
Cleared Jun 04, 2012
SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM
K120689 · HRS
Orthopedic · 90d
Cleared Feb 29, 2012
2.7MM LCP ULNA OSTEOTOMY SYSTEM
K113364 · HRS
Orthopedic · 106d
Cleared Dec 05, 2011
SYNTHES CORTICAL SCREWS
K112583 · HWC
Orthopedic · 90d
Cleared Nov 28, 2011
SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS
K111891 · HSB
Orthopedic · 146d
Cleared Nov 17, 2011
SYNTHES LCP PEDIATRIC PLATE SYSTEMS
K112085 · HRS
Orthopedic · 119d
Cleared Aug 10, 2011
SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
K111437 · HTO
Orthopedic · 78d
Cleared May 24, 2011
SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW
K111230 · HWC
Orthopedic · 22d
Cleared Jan 27, 2011
NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
K102722 · MQV
Orthopedic · 128d
Filters