The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Multifix S Knotless Fixation System.
Device ID | K151660 |
510k Number | K151660 |
Device Name: | MultiFIX S Knotless Fixation System |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | ArthroCare Corporation 15285 Alton Parkway, Suite 200 Irvine, CA 92618 |
Contact | Laura Kasperowicz |
Correspondent | Laura Kasperowicz ArthroCare Corporation 15285 Alton Parkway, Suite 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 | 2015-06-19 |
Decision Date | 2015-07-16 |
Summary: | summary |