The following data is part of a premarket notification filed by Signature Orthopaedics Pty Ltd. with the FDA for 40-42mm Bipolar Head And 22mm Femoral Head.
| Device ID | K163081 |
| 510k Number | K163081 |
| Device Name: | 40-42mm BiPolar Head And 22mm Femoral Head |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or 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 | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-03 |
| Decision Date | 2018-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09348215017903 | K163081 | 000 |
| 09348215112516 | K163081 | 000 |
| 09348215112523 | K163081 | 000 |
| 09348215045470 | K163081 | 000 |
| 09348215017293 | K163081 | 000 |
| 09348215017309 | K163081 | 000 |
| 09348215017316 | K163081 | 000 |
| 09348215017323 | K163081 | 000 |
| 09348215072605 | K163081 | 000 |
| 09348215072612 | K163081 | 000 |
| 09348215072629 | K163081 | 000 |
| 09348215072636 | K163081 | 000 |
| 09348215072643 | K163081 | 000 |
| 09348215072650 | K163081 | 000 |
| 09348215072667 | K163081 | 000 |
| 09348215072674 | K163081 | 000 |
| 09348215017880 | K163081 | 000 |
| 09348215017897 | K163081 | 000 |
| 09348215112509 | K163081 | 000 |