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 |