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510(k) K203121

Responsive Arthroscopy Thunderbolt System by Responsive Arthroscopy, LLC — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2021
Date Received
October 16, 2020
Clearance Type
Traditional
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

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  • K253695 — LigaMend (February 27, 2026)
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  • K260004 — Aevumed PROTEKT Suture Anchor (January 28, 2026)
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