The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Opus Magnum2 And Opus Magnum X Knotless Fixation Devices.
| Device ID | K083240 |
| 510k Number | K083240 |
| Device Name: | OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROCARE CORP. 15285 ALTON PARKWAY SUITE 200 Irvine, CA 92618 |
| Contact | Laura N Kasperowicz |
| Correspondent | Laura N Kasperowicz ARTHROCARE CORP. 15285 ALTON PARKWAY SUITE 200 Irvine, CA 92618 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-03 |
| Decision Date | 2009-01-12 |
| Summary: | summary |