Synthes is one of 13314 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Synthes - FDA 510(k) Cleared Devices
Recent clearances: SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM, SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM, SYNTHECEL DURA REPLACEMENT DEVICES
11
Total
11
Cleared
0
Denied
Synthes has 11 FDA 510(k) cleared orthopedic devices. Based in Paoli, US.
Historical record: 11 cleared submissions from 1998 to 2013.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Synthes
11 devices
Cleared
Sep 05, 2013
SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
Neurology
275d
Cleared
Apr 11, 2013
SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM
Orthopedic
241d
Cleared
CT
Jan 09, 2012
SYNTHECEL DURA REPLACEMENT DEVICES
Neurology
84d
Cleared
Dec 13, 2011
VBB SYSTEM
Orthopedic
285d
Cleared
Mar 29, 2010
SYNTHES STERNAL FIXATION SYSTEM
Orthopedic
111d
Cleared
Nov 26, 2002
CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)
Orthopedic
439d
Cleared
May 20, 2002
SYNTHES PILON PLATE
Orthopedic
87d
Cleared
Jun 06, 2001
USS-LINE EXTENSION
Orthopedic
145d
Cleared
May 29, 2001
SYNTHES SYNEX SPACER SYSTEM
Orthopedic
168d
Cleared
Oct 30, 2000
SYNTHES USS (10.0MM SIDE OPENING SCREWS)
Orthopedic
28d
Cleared
Oct 08, 1998
SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)
Orthopedic
64d