Orthosoft, Inc.
Montreal, Quebec, CA
Orthosoft, Inc. appears in FDA device records in Montreal, Quebec, CA. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Orthosoft, Inc. between 1998 and 2013. The busiest year on record is 2003, with 4. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 2000 | 1 |
| 2002 | 1 |
| 2003 | 4 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 2 |
| 2010 | 1 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K131409 | CAS PSI KNEE SYSTEM | JWH | Substantially Equivalent | |
| K100599 | CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM | OLO | Substantially Equivalent | |
| K071929 | NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL | HAW | Substantially Equivalent | |
| K071714 | NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003 | HAW | Substantially Equivalent | |
| K060336 | NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 | HAW | Substantially Equivalent | |
| K043536 | NAVITRACK SYSTEM - S&N IMAGE FREE KNEE | HAW | Substantially Equivalent | |
| K041369 | NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017 | HAW | Substantially Equivalent | |
| K032917 | NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE | HAW | Substantially Equivalent | |
| K030827 | NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204 | HAW | Substantially Equivalent | |
| K031156 | NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005 | HAW | Substantially Equivalent | |
| K022364 | NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200 | HAW | Substantially Equivalent | |
| K021760 | NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120 | HAW | Substantially Equivalent | |
| K002053 | NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004 | HAW | Substantially Equivalent | |
| K981315 | NAVITRACK | HAW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain