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 |