The following data is part of a premarket notification filed by Alphatec Spine, Inc with the FDA for Atec Iom Accessory Instruments.
| Device ID | K182617 |
| 510k Number | K182617 |
| Device Name: | ATEC IOM Accessory Instruments |
| Classification | Neurosurgical Nerve Locator |
| Applicant | Alphatec Spine, Inc 5818 El Camino Real Carlsbad, CA 92008 |
| Contact | Jeremy Markovich |
| Correspondent | Jeremy Markovich Alphatec Spine, Inc 5818 El Camino Real Carlsbad, CA 92008 |
| Product Code | PDQ |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-24 |
| Decision Date | 2019-05-09 |