The following data is part of a premarket notification filed by Alphatec Mfg., Inc. with the FDA for Pylon Intramedullaary Nail System.
| Device ID | K992350 |
| 510k Number | K992350 |
| Device Name: | PYLON INTRAMEDULLAARY NAIL SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| 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 | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-14 |
| Decision Date | 1999-09-22 |
| Summary: | summary |