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 | K181340 |
| 510k Number | K181340 |
| Device Name: | Cemented TSI Hip Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-21 |
| Decision Date | 2019-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09348215040604 | K181340 | 000 |
| 09348215072599 | K181340 | 000 |
| 09348215087449 | K181340 | 000 |
| 09348215087432 | K181340 | 000 |
| 09348215087425 | K181340 | 000 |
| 09348215087418 | K181340 | 000 |
| 09348215087401 | K181340 | 000 |
| 09348215087395 | K181340 | 000 |
| 09348215087388 | K181340 | 000 |
| 09348215087371 | K181340 | 000 |
| 09348215087364 | K181340 | 000 |
| 09348215087357 | K181340 | 000 |
| 09348215087340 | K181340 | 000 |
| 09348215087333 | K181340 | 000 |
| 09348215087326 | K181340 | 000 |
| 09348215087319 | K181340 | 000 |
| 09348215087302 | K181340 | 000 |
| 09348215040444 | K181340 | 000 |
| 09348215040451 | K181340 | 000 |
| 09348215040598 | K181340 | 000 |
| 09348215040581 | K181340 | 000 |
| 09348215040574 | K181340 | 000 |
| 09348215040567 | K181340 | 000 |
| 09348215040550 | K181340 | 000 |
| 09348215051259 | K181340 | 000 |
| 09348215040543 | K181340 | 000 |
| 09348215040536 | K181340 | 000 |
| 09348215051327 | K181340 | 000 |
| 09348215040529 | K181340 | 000 |
| 09348215040512 | K181340 | 000 |
| 09348215040505 | K181340 | 000 |
| 09348215040499 | K181340 | 000 |
| 09348215040482 | K181340 | 000 |
| 09348215040475 | K181340 | 000 |
| 09348215040468 | K181340 | 000 |
| 09348215087296 | K181340 | 000 |