K060121 is an FDA 510(k) clearance for the BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS. This device is classified as a Neurological Stereotaxic Instrument (Class II - Special Controls, product code HAW).
Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on March 21, 2006, 63 days after receiving the submission on January 17, 2006.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4560.
| 510(k) Number | K060121 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2006 |
| Decision Date | March 21, 2006 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| 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 |