The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Solitude Unipolar Head.
| Device ID | K042973 |
| 510k Number | K042973 |
| Device Name: | SOLITUDE UNIPOLAR HEAD |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| 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 | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-28 |
| Decision Date | 2005-01-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822409015078 | K042973 | 000 |
| 00822409014927 | K042973 | 000 |
| 00822409014910 | K042973 | 000 |
| 00822409014903 | K042973 | 000 |
| 00822409014897 | K042973 | 000 |
| 00822409014880 | K042973 | 000 |
| 00822409014873 | K042973 | 000 |
| 00822409014866 | K042973 | 000 |
| 00822409014859 | K042973 | 000 |
| 00822409014842 | K042973 | 000 |
| 00822409014835 | K042973 | 000 |
| 00822409014828 | K042973 | 000 |
| 00822409014811 | K042973 | 000 |
| 00822409014934 | K042973 | 000 |
| 00822409014941 | K042973 | 000 |
| 00822409015061 | K042973 | 000 |
| 00822409015054 | K042973 | 000 |
| 00822409015047 | K042973 | 000 |
| 00822409015030 | K042973 | 000 |
| 00822409015023 | K042973 | 000 |
| 00822409015016 | K042973 | 000 |
| 00822409015009 | K042973 | 000 |
| 00822409014996 | K042973 | 000 |
| 00822409014989 | K042973 | 000 |
| 00822409014972 | K042973 | 000 |
| 00822409014965 | K042973 | 000 |
| 00822409014958 | K042973 | 000 |
| 00822409014804 | K042973 | 000 |