The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Atec Iom Accessory Instruments.
| Device ID | K221821 |
| 510k Number | K221821 |
| Device Name: | ATEC IOM Accessory Instruments |
| Classification | Neurosurgical Nerve Locator |
| Applicant | Alphatec Spine, Inc. 1950 Camino Vido Roble Carlsbad, CA 92008 |
| Contact | Sandy Gill |
| Correspondent | Sandy Gill Alphatec Spine, Inc. 1950 Camino Vido Roble 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 | 2022-06-23 |
| Decision Date | 2022-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190376467825 | K221821 | 000 |
| 00190376471358 | K221821 | 000 |
| 00190376471341 | K221821 | 000 |
| 00190376471334 | K221821 | 000 |