Orthosoft, Inc. is one of 404 FDA 510(k) medical device manufacturers from Canada in the dataset, ranked by real submission volume.
Orthosoft, Inc. - FDA 510(k) Cleared Devices
Recent clearances: CAS PSI KNEE SYSTEM, NAVITRACK SYSTEM - S&N IMAGE FREE KNEE, NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017
14
Total
14
Cleared
0
Denied
Orthosoft, Inc. has 14 FDA 510(k) cleared neurology devices. Based in Montreal, Quebec, CA.
Historical record: 14 cleared submissions from 1998 to 2013.
Browse the complete list of FDA 510(k) cleared neurology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Orthosoft, Inc.
14 devices
Cleared
Sep 13, 2013
CAS PSI KNEE SYSTEM
Orthopedic
121d
Cleared
Apr 05, 2010
CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR,...
Orthopedic
33d
Cleared
Sep 19, 2007
NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL
Neurology
68d
Cleared
Jul 20, 2007
NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003
Neurology
28d
Cleared
Apr 28, 2006
NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002
Neurology
77d
Cleared
Jan 14, 2005
NAVITRACK SYSTEM - S&N IMAGE FREE KNEE
Neurology
23d
Cleared
Jun 22, 2004
NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017
Neurology
29d
Cleared
Oct 21, 2003
NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE
Neurology
29d
Cleared
May 23, 2003
NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204
Neurology
70d
Cleared
May 09, 2003
NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005
Neurology
28d
Cleared
Feb 04, 2003
NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200
Neurology
197d
Cleared
Aug 27, 2002
NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120
Neurology
90d