Submission Details
| 510(k) Number | K063729 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00
Aug 2007
Decision
249d
Days
Class 2
Risk
About This 510(k) Submission
K063729 is an FDA 510(k) clearance for the DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00, 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 review panel. Regulated under 21 CFR 882.1350.
Device Classification
| Product Code | GXZ — Electrode, Needle |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.1350 |
Manufacturer
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