The following data is part of a premarket notification filed by Signature Orthopaedics Pty Ltd. with the FDA for Cemented Tsi Hip Stem.
| Device ID | K192024 |
| 510k Number | K192024 |
| Device Name: | Cemented TSI Hip Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| 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 | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-29 |
| Decision Date | 2020-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09348215054557 | K192024 | 000 |
| 09348215054540 | K192024 | 000 |
| 09348215054533 | K192024 | 000 |
| 09348215054526 | K192024 | 000 |
| 09348215054519 | K192024 | 000 |
| 09348215054502 | K192024 | 000 |