The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Hemisphere Modular Cup System.
| Device ID | K000321 |
| 510k Number | K000321 |
| Device Name: | HEMISPHERE MODULAR CUP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-02 |
| Decision Date | 2000-04-10 |