Responsive Arthroscopy Interference Screw System

Screw, Fixation, Bone

Responsive Arthroscopy LLC

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

Pre-market Notification Details

Device IDK202569
510k NumberK202569
Device Name:Responsive Arthroscopy Interference Screw System
ClassificationScrew, Fixation, Bone
Applicant Responsive Arthroscopy LLC 701 N. 3rd Street, Suite 208 Minneapolis,  MN  55401
ContactDouglas Kohrs
CorrespondentKristen Pena
Cor Medical Ventures 215 S. Highway 101, Suite 200 Solana Beach,  CA  92075
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-04
Decision Date2020-09-23

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