K100314 is an FDA 510(k) clearance for the IMNS MEDACTA NAVIGATION SYSTEM,33.221000US. This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by Medacta International S.A. (Camarillo, US). The FDA issued a Cleared decision on March 31, 2010, 55 days after receiving the submission on February 4, 2010.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K100314 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2010 |
| Decision Date | March 31, 2010 |
| Days to Decision | 55 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HAW — Neurological Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4560 |