Responsive Arthroscopy Suture Anchor System

Fastener, Fixation, Nondegradable, Soft Tissue

Responsive Arthroscopy LLC

The following data is part of a premarket notification filed by Responsive Arthroscopy Llc with the FDA for Responsive Arthroscopy Suture Anchor System.

Pre-market Notification Details

Device IDK202153
510k NumberK202153
Device Name:Responsive Arthroscopy Suture Anchor System
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Responsive Arthroscopy LLC 701 N. 3rd Street, Suite 208 Minneapolis,  MN  55401
ContactDouglas Korhs
CorrespondentKristen Pena
Cor Medical Ventures LLC 215 S. Highway 101 Suite 200 Solana Beach,  CA  92075
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-03
Decision Date2020-09-09

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