The following data is part of a premarket notification filed by Orthofix Srl with the FDA for Orthofix Titanium Humeral Plating System Lsp.
| Device ID | K062920 |
| 510k Number | K062920 |
| Device Name: | ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Applicant | ORTHOFIX SRL 15058 ARMEL DR. Oregon City, OR 97045 |
| Contact | Candace F Cederman |
| Correspondent | Candace F Cederman ORTHOFIX SRL 15058 ARMEL DR. Oregon City, OR 97045 |
| Product Code | KTW |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-28 |
| Decision Date | 2006-11-13 |
| Summary: | summary |