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510(k) K190446

Responsive Arthroscopy Wedge Push-In Suture Anchors by Responsive Arthroscopy, LLC — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2019
Date Received
February 25, 2019
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

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  • K181076 — Responsive Arthroscopy Wedge Push-In Suture Anchors (January 18, 2019)
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  • K254229 — Arthrex Nano FiberTak Suture Anchor (March 2, 2026)
  • K253695 — LigaMend (February 27, 2026)
  • K253763 — Y-Knotless™ Flex Anchors (January 29, 2026)
  • K260004 — Aevumed PROTEKT Suture Anchor (January 28, 2026)
  • K253618 — QuadLock™ Fixation System (January 6, 2026)