Medical Device Manufacturer · CA , Montreal, Quebec

Orthosoft, Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 1998

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Orthosoft, Inc. Neurology ✕

12 devices

1-12 of 12

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

Cleared Aug 03, 2000

NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004

Neurology · 28d

Cleared Jul 09, 1998

Neurology · 90d