510(k) K041369 ยท HAW Neurological Stereotaxic Instrument
NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017
| Applicant | Orthosoft, Inc., Montreal, CA |
| Decision | Substantially Equivalent, Jun 22, 2004 |
| Received | May 24, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041369
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2008 | Zimmer Inc. Quicklock Tracker, Size 2, Manufactured by Orthosoft, Montreal, Canada; Distributed by Smith & Nephew, Inc., Memphis, TN; ref: 111.100. Device is a surgical instrument. Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.