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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09348215077037 | K212870 | 000 |
| 09348215077150 | K212870 | 000 |
| 09348215077167 | K212870 | 000 |
| 09348215077174 | K212870 | 000 |
| 09348215077181 | K212870 | 000 |
| 09348215077198 | K212870 | 000 |
| 09348215077204 | K212870 | 000 |
| 09348215077211 | K212870 | 000 |
| 09348215077228 | K212870 | 000 |
| 09348215077143 | K212870 | 000 |
| 09348215077136 | K212870 | 000 |
| 09348215077129 | K212870 | 000 |
| 09348215077044 | K212870 | 000 |
| 09348215077051 | K212870 | 000 |
| 09348215077068 | K212870 | 000 |
| 09348215077075 | K212870 | 000 |
| 09348215077082 | K212870 | 000 |
| 09348215077099 | K212870 | 000 |
| 09348215077105 | K212870 | 000 |
| 09348215077112 | K212870 | 000 |
| 09348215077235 | K212870 | 000 |
| 09348215077242 | K212870 | 000 |
| 09348215077525 | K212870 | 000 |
| 09348215077549 | K212870 | 000 |
| 09348215077563 | K212870 | 000 |
| 09348215077600 | K212870 | 000 |
| 09348215077624 | K212870 | 000 |
| 09348215077648 | K212870 | 000 |
| 09348215077686 | K212870 | 000 |
| 09348215077709 | K212870 | 000 |
| 09348215077488 | K212870 | 000 |
| 09348215077464 | K212870 | 000 |
| 09348215077440 | K212870 | 000 |
| 09348215077259 | K212870 | 000 |
| 09348215077266 | K212870 | 000 |
| 09348215077297 | K212870 | 000 |
| 09348215077310 | K212870 | 000 |
| 09348215077334 | K212870 | 000 |
| 09348215077365 | K212870 | 000 |
| 09348215077389 | K212870 | 000 |
| 09348215077402 | K212870 | 000 |
| 09348215077723 | K212870 | 000 |