The following data is part of a premarket notification filed by Portland Orthopaedics Pty. Ltd. with the FDA for Equator Plus Acetabular Cup System.
| Device ID | K051844 |
| 510k Number | K051844 |
| Device Name: | EQUATOR PLUS ACETABULAR CUP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish |
| 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 | MAY |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LWJ |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-07 |
| Decision Date | 2005-10-07 |
| Summary: | summary |