The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Atec Alignment App.
| Device ID | K211987 |
| 510k Number | K211987 |
| Device Name: | ATEC Alignment App |
| Classification | System, Image Processing, Radiological |
| Applicant | Alphatec Spine, Inc. 1950 Camina Vida Roble Carlsbad, CA 92008 |
| Contact | David Gramse |
| Correspondent | David Gramse Alphatec Spine, Inc. 1950 Camino Vida Roble Carlsbad, CA 92008 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-28 |
| Decision Date | 2021-10-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190376470351 | K211987 | 000 |