The following data is part of a premarket notification filed by Opus Medical, Inc. with the FDA for Opus Magnum Anchor With Inserter.
| Device ID | K041440 |
| 510k Number | K041440 |
| Device Name: | OPUS MAGNUM ANCHOR WITH INSERTER |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | OPUS MEDICAL, INC. 27127 CALLE ARROYO, SUITE 1924 San Juan Capistrano, CA 92675 |
| Contact | Laura N Kasperowicz |
| Correspondent | Laura N Kasperowicz OPUS MEDICAL, INC. 27127 CALLE ARROYO, SUITE 1924 San Juan Capistrano, CA 92675 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-01 |
| Decision Date | 2004-06-25 |
| Summary: | summary |