The following data is part of a premarket notification filed by Portland Orthopaedics Pty. Ltd. with the FDA for M-cor Hip Replacement System.
| Device ID | K053417 |
| 510k Number | K053417 |
| Device Name: | M-COR HIP REPLACEMENT SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | PORTLAND ORTHOPAEDICS PTY. LTD. PO BOX 560 Stillwater, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan PORTLAND ORTHOPAEDICS PTY. LTD. PO BOX 560 Stillwater, MN 55082 |
| Product Code | LPH |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-08 |
| Decision Date | 2006-07-20 |
| Summary: | summary |