The following data is part of a premarket notification filed by Spine Guard S.a. with the FDA for Pediguard Threaded.
| Device ID | K220160 |
| 510k Number | K220160 |
| Device Name: | PediGuard Threaded |
| Classification | Neurosurgical Nerve Locator |
| Applicant | Spine Guard S.A. 10 Cours Louis Lumiere Vincennes, FR 94300 |
| Contact | Stephane Bette |
| Correspondent | John Smith Hogan Lovells LLP 555 Thirteenth Street 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 | 2022-01-19 |
| Decision Date | 2022-03-31 |