The following data is part of a premarket notification filed by Signal Medical Corporation with the FDA for Symmetric Total Knee System.
| Device ID | K203779 |
| 510k Number | K203779 |
| Device Name: | Symmetric Total Knee System |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | Signal Medical Corporation 400 Pyramid Dr. Marysville, MI 48040 |
| Contact | Dora Culton |
| Correspondent | Dora Culton Signal Medical Corporation 400 Pyramid Dr. Marysville, MI 48040 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-28 |
| Decision Date | 2021-06-10 |