K234092 is an FDA 510(k) clearance for the SafeOp 3: Neural Informatix Systeem. This device is classified as a Stimulator, Electrical, Evoked Response (Class II - Special Controls, product code GWF).
Submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on April 19, 2024, 115 days after receiving the submission on December 26, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1870.
| 510(k) Number | K234092 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2023 |
| Decision Date | April 19, 2024 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWF — Stimulator, Electrical, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1870 |