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510(k) K190375

Parcus ATLAS by Parcus Medical, LLC — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2019
Date Received
February 19, 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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  • 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)
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