The following data is part of a premarket notification filed by Technomed Europe with the FDA for Disposable Pedicle Screw Probe, Model 3603-00.
| Device ID | K063729 |
| 510k Number | K063729 |
| Device Name: | DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 |
| Classification | Electrode, Needle |
| Applicant | TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport, NL 6199 Ae |
| Contact | Maurice Roost |
| Correspondent | Maurice Roost TECHNOMED EUROPE AMERIKALAAN 71 Maastricht Airport, NL 6199 Ae |
| Product Code | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-15 |
| Decision Date | 2007-08-21 |
| Summary: | summary |