The following data is part of a premarket notification filed by Portland Orthopaedics Pty. Ltd. with the FDA for Modification To: The Margron Hip Replacement System.
| Device ID | K032641 |
| 510k Number | K032641 |
| Device Name: | MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | PORTLAND ORTHOPAEDICS PTY. LTD. 3/44 MCCAULEY ST. Matraville Nsw, AU 2036 |
| Contact | David Sekel |
| Correspondent | David Sekel PORTLAND ORTHOPAEDICS PTY. LTD. 3/44 MCCAULEY ST. Matraville Nsw, AU 2036 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-27 |
| Decision Date | 2004-01-20 |
| Summary: | summary |