The following data is part of a premarket notification filed by Alphatec Mfg., Inc. with the FDA for Alphatec External Fixation System Compression/distraction Rod.
| Device ID | K993873 |
| 510k Number | K993873 |
| Device Name: | ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ALPHATEC MFG., INC. 42-160 STATE ST. Palm Desert, CA 92211 -5148 |
| Contact | Jason Blain |
| Correspondent | Jason Blain 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 | 1999-11-15 |
| Decision Date | 2000-01-03 |
| Summary: | summary |