The following data is part of a premarket notification filed by Alphatec Mfg., Inc. with the FDA for Alpha Spinal System.
| Device ID | K930515 |
| 510k Number | K930515 |
| Device Name: | ALPHA SPINAL SYSTEM |
| 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 - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-01 |
| Decision Date | 1994-06-29 |