The following data is part of a premarket notification filed by Alphatec Mfg., Inc. with the FDA for Mirage Spinal System For Severe Spondylolisthesis.
| Device ID | K951846 |
| 510k Number | K951846 |
| Device Name: | MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | ALPHATEC MFG., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf ALPHATEC MFG., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-20 |
| Decision Date | 1996-02-14 |