The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for European Style Taper,press-fit Hip Stem.
| Device ID | K062775 |
| 510k Number | K062775 |
| Device Name: | EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-18 |
| Decision Date | 2007-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00822409011216 | K062775 | 000 |
| 00822409010905 | K062775 | 000 |
| 00822409010899 | K062775 | 000 |
| 00822409010882 | K062775 | 000 |
| 00822409010875 | K062775 | 000 |
| 00822409010868 | K062775 | 000 |
| 00822409010851 | K062775 | 000 |
| 00822409010844 | K062775 | 000 |
| 00822409010837 | K062775 | 000 |
| 00822409010820 | K062775 | 000 |
| 00822409010813 | K062775 | 000 |
| 00822409010912 | K062775 | 000 |
| 00822409011087 | K062775 | 000 |
| 00822409011186 | K062775 | 000 |
| 00822409011179 | K062775 | 000 |
| 00822409011162 | K062775 | 000 |
| 00822409011155 | K062775 | 000 |
| 00822409011148 | K062775 | 000 |
| 00822409011131 | K062775 | 000 |
| 00822409011124 | K062775 | 000 |
| 00822409011117 | K062775 | 000 |
| 00822409011100 | K062775 | 000 |
| 00822409011094 | K062775 | 000 |
| 00822409010806 | K062775 | 000 |