The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Hemisphere Cemented Cup.
| Device ID | K971581 |
| 510k Number | K971581 |
| Device Name: | HEMISPHERE CEMENTED CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | ORTHO DEVELOPMENT CORP. 106 WEST 12200 SOUTH Draper, UT 84020 |
| Contact | Carol Freasier |
| Correspondent | Carol Freasier ORTHO DEVELOPMENT CORP. 106 WEST 12200 SOUTH 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 | 1997-04-30 |
| Decision Date | 1997-07-18 |