K213849 is an FDA 510(k) clearance for the SafeOp 2: Neural Informatix System. 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 March 9, 2022, 89 days after receiving the submission on December 10, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1870.
| 510(k) Number | K213849 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2021 |
| Decision Date | March 09, 2022 |
| Days to Decision | 89 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 |