The following data is part of a premarket notification filed by Synthes (usa) Products, Llc with the FDA for Titanium Tomofix Medial High Tibia Plate Anatomical.
| Device ID | K180213 |
| 510k Number | K180213 |
| Device Name: | Titanium TomoFix Medial High Tibia Plate Anatomical |
| Classification | Plate, Fixation, Bone |
| Applicant | Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Stephan Jepards |
| Correspondent | Stephan Jepards Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-25 |
| Decision Date | 2018-10-19 |