The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Atec Iom Accessory Instruments.
| Device ID | K191723 |
| 510k Number | K191723 |
| Device Name: | ATEC IOM Accessory Instruments |
| Classification | Neurosurgical Nerve Locator |
| Applicant | Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 |
| Contact | Ruby Zheng |
| Correspondent | Ruby Zheng 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 | 2019-06-27 |
| Decision Date | 2019-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190376232300 | K191723 | 000 |
| 00840180503850 | K191723 | 000 |
| 00190376240268 | K191723 | 000 |
| 00190376240275 | K191723 | 000 |
| 00190376189536 | K191723 | 000 |
| 00190376189543 | K191723 | 000 |
| 00190376189550 | K191723 | 000 |
| 00190376215877 | K191723 | 000 |
| 00190376215884 | K191723 | 000 |
| 00190376232294 | K191723 | 000 |
| 00190376394640 | K191723 | 000 |