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510(k) K192750

AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip by Parcus Medical, LLC — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2020
Date Received
September 30, 2019
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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  • 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)
  • K192964 — Parcus Synd-EZ SS (November 22, 2019)
  • K192824 — Parcus Knotless AP Suture Anchors (November 2, 2019)

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