K152747 is an FDA 510(k) clearance for the DSG Threaded Drill System. This device is classified as a Neurosurgical Nerve Locator (Class II - Special Controls, product code PDQ).
Submitted by Spineguard S.A. (Vincennes, FR). The FDA issued a Cleared decision on June 10, 2016, 261 days after receiving the submission on September 23, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 874.1820. To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery..
| 510(k) Number | K152747 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2015 |
| Decision Date | June 10, 2016 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | PDQ - Neurosurgical Nerve Locator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.1820 |
| Definition | To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery. |