Navitrack System - S&N Image Free Knee
FDA 510(k) K043536 · Orthosoft, Inc.
510(k) numberK043536
Submission
- Device name
- Navitrack System - S&N Image Free Knee
- Applicant
- Orthosoft, Inc.
Montreal, CA - Received
- December 22, 2004
- Decision date
- January 14, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K071714 | Navitrack System - Os Unicondylar Knee Universal, Model# PRO-06003HAW · Special | 07/20/2007SE |
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| K041369 | Navitrack System - S&N Image Free Hip, Model PRO-03017HAW · Special | 06/22/2004SE |
| K032917 | Navitrack System - Total Hip Replacement Ct-FreeHAW · Special | 10/21/2003SE |
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| K031156 | Navitrack System-Fluorospine, Model 900.005HAW · Special | 05/09/2003SE |
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Questions and answers
When was Navitrack System - S&N Image Free Knee cleared by the FDA?
Navitrack System - S&N Image Free Knee (K043536) received a 510(k) decision of Substantially Equivalent on January 14, 2005, 23 days after the submission was received.
What is the product code of K043536?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.