The following data is part of a premarket notification filed by Alphatec Mfg., Inc. with the FDA for Alphatec External Fixation System.
| Device ID | K964400 |
| 510k Number | K964400 |
| Device Name: | ALPHATEC EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ALPHATEC MFG., INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
| Contact | Kenneth J Kisco |
| Correspondent | Kenneth J Kisco ALPHATEC MFG., INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-04 |
| Decision Date | 1997-04-28 |