The following data is part of a premarket notification filed by Opus Medical, Inc. with the FDA for Opus Magnum Implant System, Model Om-1500.
| Device ID | K031083 |
| 510k Number | K031083 |
| Device Name: | OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500 |
| Classification | Pin, Fixation, Smooth |
| Applicant | OPUS MEDICAL, INC. 27127 CALLE ARROYO, SUITE 1924 San Juan Capistrano, CA 92675 |
| Contact | James W Hart |
| Correspondent | James W Hart OPUS MEDICAL, INC. 27127 CALLE ARROYO, SUITE 1924 San Juan Capistrano, CA 92675 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-04 |
| Decision Date | 2003-06-12 |