The following data is part of a premarket notification filed by Alphatec Mfg., Inc. with the FDA for Alphatec Compression And Reconstruction Plates.
| Device ID | K922167 |
| 510k Number | K922167 |
| Device Name: | ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | ALPHATEC MFG., INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
| Contact | Thomas A Hoghaug |
| Correspondent | Thomas A Hoghaug 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 | 1992-05-08 |
| Decision Date | 1992-08-06 |