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510(k) K182736

OIC Suture Anchor System by The Orthopaedic Implant Company — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2018
Date Received
September 28, 2018
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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  • K212601 — DRPx Locking Distal Radius Plate System (April 5, 2022)
  • K202971 — DRPx Locking Distal Radius Plate System (May 6, 2021)
  • K211112 — OIC External Fixation System (May 5, 2021)
  • K183682 — OIC External Fixation System (April 8, 2019)
  • K181184 — OIC Intramedullary Nail System (July 27, 2018)
  • K171211 — OIC External Fixation System (September 27, 2017)

Other clearances for product code MBI

  • K251750 — Trax EX Anchor (March 12, 2026)
  • K253693 — Strut Suture; No-Tie Button (March 11, 2026)
  • K260405 — FiberTape Button (March 9, 2026)
  • K253538 — TeKBrace Knotless Anchor (March 6, 2026)
  • K254306 — Aevumed FENIX Suture Anchor (March 4, 2026)
  • 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)