The following data is part of a premarket notification filed by Meridian Medical with the FDA for Pta (progressive Tibial Alignment).
| Device ID | K060403 |
| 510k Number | K060403 |
| Device Name: | PTA (PROGRESSIVE TIBIAL ALIGNMENT) |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | MERIDIAN MEDICAL 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland MERIDIAN MEDICAL 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-15 |
| Decision Date | 2006-03-28 |
| Summary: | summary |