The following data is part of a premarket notification filed by Alphatec Mfg., Inc. with the FDA for Alphatec 130 Compression Hip Screw.
| Device ID | K925500 |
| 510k Number | K925500 |
| Device Name: | ALPHATEC 130 COMPRESSION HIP SCREW |
| Classification | Plate, Fixation, Bone |
| Applicant | ALPHATEC MFG., INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
| Contact | Brad Davis |
| Correspondent | Brad Davis ALPHATEC MFG., INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-30 |
| Decision Date | 1993-04-14 |