K063729 is an FDA 510(k) clearance for the DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00. This device is classified as a Electrode, Needle (Class II - Special Controls, product code GXZ).
Submitted by Technomed Europe (Maastricht-Airport, NL). The FDA issued a Cleared decision on August 21, 2007, 249 days after receiving the submission on December 15, 2006.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1350.
| 510(k) Number | K063729 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2006 |
| Decision Date | August 21, 2007 |
| Days to Decision | 249 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXZ — Electrode, Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1350 |