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510(k) K221135

X-Twist PEEK Suture Anchor by Parcus Medical, LLC — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2022
Date Received
April 19, 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

Other clearances by Parcus Medical, LLC

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  • K221502 — Parcus Synd-EZ SS (July 26, 2022)
  • K212739 — ActiFlip (October 6, 2021)
  • K202662 — Parcus Titanium Interference Screws (February 22, 2021)
  • K202259 — Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, (October 28, 2020)
  • K201083 — Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors (July 23, 2020)
  • K193295 — Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor (January 23, 2020)
  • K192750 — AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip (January 16, 2020)
  • K192964 — Parcus Synd-EZ SS (November 22, 2019)
  • K192824 — Parcus Knotless AP Suture Anchors (November 2, 2019)

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  • K254229 — Arthrex Nano FiberTak Suture Anchor (March 2, 2026)
  • K253695 — LigaMend (February 27, 2026)