The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Opus Speedscrew System.
| Device ID | K100457 |
| 510k Number | K100457 |
| Device Name: | OPUS SPEEDSCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-17 |
| Decision Date | 2010-03-19 |
| Summary: | summary |