The following data is part of a premarket notification filed by Alphatec Mfg., Inc. with the FDA for Alphatec Cannulated Bone Screws.
| Device ID | K914004 |
| 510k Number | K914004 |
| Device Name: | ALPHATEC CANNULATED BONE SCREWS |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-06 |
| Decision Date | 1991-12-05 |