The following data is part of a premarket notification filed by Alphatec Mfg., Inc. with the FDA for Deltaloc Anterior Cervical Plate System.
| Device ID | K993513 |
| 510k Number | K993513 |
| Device Name: | DELTALOC ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | ALPHATEC MFG., INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
| Contact | Jason Blain |
| Correspondent | Jason Blain ALPHATEC MFG., INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-18 |
| Decision Date | 2000-04-26 |
| Summary: | summary |