The following data is part of a premarket notification filed by Signature Orthopaedics Pty Ltd. with the FDA for Signature Ceramic Femoral Head.
| Device ID | K190704 |
| 510k Number | K190704 |
| Device Name: | Signature Ceramic Femoral Head |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-18 |
| Decision Date | 2019-08-28 |