The following data is part of a premarket notification filed by Arthocare Corporation with the FDA for Multifix S Knotless Fixation Device.
Device ID | K131182 |
510k Number | K131182 |
Device Name: | MULTIFIX S KNOTLESS FIXATION DEVICE |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | ARTHOCARE CORPORATION 7000 West William Cannon Drive Austin, TX 78735 |
Contact | Mitchell Dhority |
Correspondent | Mitchell Dhority ARTHOCARE CORPORATION 7000 West William Cannon Drive Austin, TX 78735 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-04-26 |
Decision Date | 2013-07-29 |
Summary: | summary |