The following data is part of a premarket notification filed by Responsive Arthroscopy Llc with the FDA for Responsive Arthroscopy Suture Anchor System.
|Device Name:||Responsive Arthroscopy Suture Anchor System|
|Classification||Fastener, Fixation, Nondegradable, Soft Tissue|
|Applicant||Responsive Arthroscopy LLC 701 N. 3rd Street, Suite 208 Minneapolis, MN 55401|
Cor Medical Ventures LLC 215 S. Highway 101 Suite 200 Solana Beach, CA 92075
|CFR Regulation Number||888.3040 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|