The following data is part of a premarket notification filed by Signature Orthopaedics Pty Ltd. with the FDA for Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, Cocr Femoral Head.
| Device ID | K191708 |
| 510k Number | K191708 |
| Device Name: | Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, 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 | LPH |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| Subsequent Product Code | OQG |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-26 |
| Decision Date | 2020-08-14 |