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 |