K191723 is an FDA 510(k) clearance for the ATEC IOM Accessory Instruments. This device is classified as a Neurosurgical Nerve Locator (Class II - Special Controls, product code PDQ).
Submitted by Alphatec Spine, Inc. (Carlsnad, US). The FDA issued a Cleared decision on October 18, 2019, 113 days after receiving the submission on June 27, 2019.
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 | K191723 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2019 |
| Decision Date | October 18, 2019 |
| Days to Decision | 113 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. |