The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Legend All-poly Cup.
| Device ID | K051407 |
| 510k Number | K051407 |
| Device Name: | LEGEND ALL-POLY CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper, UT 84020 |
| Contact | William J Griffin |
| Correspondent | William J Griffin ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper, UT 84020 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-31 |
| Decision Date | 2005-09-08 |