The following data is part of a premarket notification filed by Alphatec Mfg., Inc. with the FDA for Alphatec Wire External Fixation System.
| Device ID | K980788 |
| 510k Number | K980788 |
| Device Name: | ALPHATEC WIRE EXTERNAL FIXATION SYSTEM |
| Classification | Pin, Fixation, Threaded |
| Applicant | ALPHATEC MFG., INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
| Contact | Dan Pastrick |
| Correspondent | Dan Pastrick ALPHATEC MFG., INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-02 |
| Decision Date | 1998-05-22 |