The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Opus Magnum2 Knotless Fixation Device (model Om-1502), Opus Magnum X Knotless Fixation Device (model Om-1503).
| Device ID | K081497 |
| 510k Number | K081497 |
| Device Name: | OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503) |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROCARE CORP. 15285 ALTON PARKWAY, #200 Irvine, CA 92618 |
| Contact | Laura N Kasperowicz |
| Correspondent | Laura N Kasperowicz ARTHROCARE CORP. 15285 ALTON PARKWAY, #200 Irvine, CA 92618 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-29 |
| Decision Date | 2008-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470006254 | K081497 | 000 |
| 00817470006247 | K081497 | 000 |
| 00817470006230 | K081497 | 000 |
| 00817470006223 | K081497 | 000 |
| 00817470006216 | K081497 | 000 |
| 00817470005189 | K081497 | 000 |
| 00817470001211 | K081497 | 000 |