The following data is part of a premarket notification filed by Opus Medical, Inc. with the FDA for Opus Magnum Knotless Anchor With Inserter Handle.
| Device ID | K042914 |
| 510k Number | K042914 |
| Device Name: | OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE |
| 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 | 2004-10-21 |
| Decision Date | 2004-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470005585 | K042914 | 000 |
| 00817470005578 | K042914 | 000 |
| 00817470005530 | K042914 | 000 |
| 00817470005523 | K042914 | 000 |
| 00817470005486 | K042914 | 000 |
| 00817470005158 | K042914 | 000 |
| 00817470001129 | K042914 | 000 |