510(k) K030827 ยท HAW Neurological Stereotaxic Instrument
NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204
| Applicant | Orthosoft, Inc., Montreal, CA |
| Decision | Substantially Equivalent, May 23, 2003 |
| Received | Mar 14, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030827
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2008 | Zimmer Inc. Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal, Canada, REF 111.031. 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.