The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Opus Magnum Speedscrew Knotless Fixation Device, Model Om-6500.
| Device ID | K081893 |
| 510k Number | K081893 |
| Device Name: | OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500 |
| Classification | Screw, Fixation, Bone |
| Applicant | ARTHROCARE CORP. 15285 ALTON PARKWAY, #200 Irvine, CA 92618 |
| Contact | Laura Kasperowicz |
| Correspondent | Laura Kasperowicz ARTHROCARE CORP. 15285 ALTON PARKWAY, #200 Irvine, CA 92618 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-03 |
| Decision Date | 2008-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817470006414 | K081893 | 000 |
| 00817470006407 | K081893 | 000 |
| 00817470006391 | K081893 | 000 |
| 00817470006384 | K081893 | 000 |
| 00817470005196 | K081893 | 000 |
| 00817470005172 | K081893 | 000 |
| 00817470001242 | K081893 | 000 |