The following data is part of a premarket notification filed by Signature Orthopaedics Pty Ltd. with the FDA for Fusion Taper System.
| Device ID | K201047 |
| 510k Number | K201047 |
| Device Name: | Fusion Taper System |
| 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 |
| Subsequent Product Code | MBL |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-21 |
| Decision Date | 2021-04-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09348215082246 | K201047 | 000 |
| 09348215062163 | K201047 | 000 |
| 09348215062156 | K201047 | 000 |
| 09348215062149 | K201047 | 000 |
| 09348215025861 | K201047 | 000 |
| 09348215025854 | K201047 | 000 |
| 09348215025847 | K201047 | 000 |
| 09348215025830 | K201047 | 000 |
| 09348215007850 | K201047 | 000 |
| 09348215007843 | K201047 | 000 |
| 09348215080914 | K201047 | 000 |
| 09348215080921 | K201047 | 000 |
| 09348215080938 | K201047 | 000 |
| 09348215082239 | K201047 | 000 |
| 09348215082222 | K201047 | 000 |
| 09348215082215 | K201047 | 000 |
| 09348215082208 | K201047 | 000 |
| 09348215082192 | K201047 | 000 |
| 09348215082185 | K201047 | 000 |
| 09348215082178 | K201047 | 000 |
| 09348215082161 | K201047 | 000 |
| 09348215082154 | K201047 | 000 |
| 09348215007836 | K201047 | 000 |