The following data is part of a premarket notification filed by Signature Orthopaedics Pty Ltd. with the FDA for Tlc Unicompartmental Knee System.
| Device ID | K212870 |
| 510k Number | K212870 |
| Device Name: | TLC Unicompartmental Knee System |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | Signature Orthopaedics Pty Ltd. 7 Sirius Road Lane Cove, AU 2066 |
| Contact | Declan Brazil |
| Correspondent | Declan Brazil Signature Orthopaedics Pty Ltd. 7 Sirius Road Lane Cove, AU 2066 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-09 |
| Decision Date | 2022-06-16 |