Navitrack System - Total Hip Replacement Ct-Free
FDA 510(k) K032917 · Orthosoft, Inc.
510(k) numberK032917
Submission
- Device name
- Navitrack System - Total Hip Replacement Ct-Free
- Applicant
- Orthosoft, Inc.
Montreal, CA - Received
- September 22, 2003
- Decision date
- October 21, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K043536 | Navitrack System - S&N Image Free KneeHAW · Special | 01/14/2005SE |
| K041369 | Navitrack System - S&N Image Free Hip, Model PRO-03017HAW · Special | 06/22/2004SE |
| K030827 | Navitrack System: Total Hip Replacement Ct-Free Cup, Model 900.204HAW · Traditional | 05/23/2003SE |
| K031156 | Navitrack System-Fluorospine, Model 900.005HAW · Special | 05/09/2003SE |
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Questions and answers
When was Navitrack System - Total Hip Replacement Ct-Free cleared by the FDA?
Navitrack System - Total Hip Replacement Ct-Free (K032917) received a 510(k) decision of Substantially Equivalent on October 21, 2003, 29 days after the submission was received.
What is the product code of K032917?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.