The following data is part of a premarket notification filed by Spineguard, S.a. with the FDA for Dsg Threaded Drill System.
| Device ID | K152747 |
| 510k Number | K152747 |
| Device Name: | DSG Threaded Drill System |
| Classification | Neurosurgical Nerve Locator |
| Applicant | SPINEGUARD, S.A. 10 COURS LOUIS LUMIERE Vincennes, FR 94300 |
| Contact | Stephane Bette |
| Correspondent | John J. Smith HOGAN LOVELLS US LLP 555 THIRTEENTH ST. 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 | 2015-09-23 |
| Decision Date | 2016-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03662674000198 | K152747 | 000 |
| 03662674000174 | K152747 | 000 |