The following data is part of a premarket notification filed by Opus Medical, Inc. with the FDA for Opus Minimagnum Anchor With Inserter.
| Device ID | K042584 |
| 510k Number | K042584 |
| Device Name: | OPUS MINIMAGNUM ANCHOR WITH INSERTER |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-22 |
| Decision Date | 2004-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470005615 | K042584 | 000 |
| 00817470005608 | K042584 | 000 |
| 00817470005592 | K042584 | 000 |
| 00817470001068 | K042584 | 000 |