Home / 510(k) Clearances / K202259

510(k) K202259

Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip by Parcus Medical, LLC — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2020
Date Received
August 10, 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

Other clearances by Parcus Medical, LLC

  • K232513 — X-Twist Biocomposite Suture Anchor (September 18, 2023)
  • K221502 — Parcus Synd-EZ SS (July 26, 2022)
  • K221135 — X-Twist PEEK Suture Anchor (May 19, 2022)
  • K212739 — ActiFlip (October 6, 2021)
  • K202662 — Parcus Titanium Interference Screws (February 22, 2021)
  • 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)

Other clearances for product code MBI

  • K260561 — Arthrex FiberTak Suture Anchor (March 20, 2026)
  • K253886 — Grappler Suture Anchor PCFD Tether System (March 17, 2026)
  • K254176 — SINEFIX (March 16, 2026)
  • 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)