The following data is part of a premarket notification filed by Portland Orthopaedics Pty. Ltd. with the FDA for The Margron Hip Replacement System.
| Device ID | K992815 |
| 510k Number | K992815 |
| Device Name: | THE MARGRON HIP REPLACEMENT SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | PORTLAND ORTHOPAEDICS PTY. LTD. SUITE 3 LEVEL 5 ST. GEORGE PRIVATE HOSPITAL 1 SOUTH ST. Kogarah, New South Wales, AU Nsw 2217 |
| Contact | Ronald Sekel |
| Correspondent | Ronald Sekel PORTLAND ORTHOPAEDICS PTY. LTD. SUITE 3 LEVEL 5 ST. GEORGE PRIVATE HOSPITAL 1 SOUTH ST. Kogarah, New South Wales, AU Nsw 2217 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-20 |
| Decision Date | 2000-02-07 |
| Summary: | summary |