The following data is part of a premarket notification filed by Alphatec Mfg., Inc. with the FDA for Alpha Mirage Top Tightening Spinal System.
| Device ID | K020356 |
| 510k Number | K020356 |
| Device Name: | ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | ALPHATEC MFG., INC. 6110 CORTE DEL CEDRO Carlsbad, CA 92009 |
| Contact | Ellen A Hicks |
| Correspondent | Ellen A Hicks ALPHATEC MFG., INC. 6110 CORTE DEL CEDRO Carlsbad, CA 92009 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-04 |
| Decision Date | 2002-07-23 |
| Summary: | summary |