510(k) K222763

Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors by Responsive Arthroscopy, LLC — Product Code MBI

K222763 is an FDA 510(k) premarket notification submitted by Responsive Arthroscopy, LLC for the device "Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors". The FDA issued a decision of Substantially Equivalent on October 13, 2022. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Responsive Arthroscopy, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2022
Date Received
September 13, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type