K131851 is an FDA 510(k) clearance for the OSTEOMED NEURO RONGEUR. This device is classified as a Rongeur, Manual (Class II - Special Controls, product code HAE).
Submitted by Osteomed (Addison, US). The FDA issued a Cleared decision on December 6, 2013, 168 days after receiving the submission on June 21, 2013.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4840.
| 510(k) Number | K131851 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2013 |
| Decision Date | December 06, 2013 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HAE - Rongeur, Manual |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4840 |