The following data is part of a premarket notification filed by Spineguard, S.a. with the FDA for Pediguard Nerve Detector System.
| Device ID | K123390 |
| 510k Number | K123390 |
| Device Name: | PEDIGUARD NERVE DETECTOR SYSTEM |
| Classification | Neurosurgical Nerve Locator |
| Applicant | SPINEGUARD, S.A. 555 13TH ST. NW Washington, DC 20004 |
| Contact | John J Smith, M.d. J.d. |
| Correspondent | John J Smith, M.d. J.d. SPINEGUARD, S.A. 555 13TH ST. NW Washington, DC 20004 |
| Product Code | PDQ |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-02 |
| Decision Date | 2013-08-08 |