The following data is part of a premarket notification filed by Signature Orthopaedics, Pty, Ltd with the FDA for Origin Hip Stem, Femoral Head, Logical Px-series Acetabular Shell, Locigal G-series Acetabular Shell, Logical Acetabular.
| Device ID | K121297 |
| 510k Number | K121297 |
| Device Name: | ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | SIGNATURE ORTHOPAEDICS, PTY, LTD 125 GREVILLE ST Chatswood, AT 2067 |
| Contact | Declan Brazil |
| Correspondent | Declan Brazil SIGNATURE ORTHOPAEDICS, PTY, LTD 125 GREVILLE ST Chatswood, AT 2067 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-30 |
| Decision Date | 2012-12-28 |
| Summary: | summary |