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Parcus Medical, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
31
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K232513X-Twist Biocomposite Suture AnchorSeptember 18, 2023
K221502Parcus Synd-EZ SSJuly 26, 2022
K221135X-Twist PEEK Suture AnchorMay 19, 2022
K212739ActiFlipOctober 6, 2021
K202662Parcus Titanium Interference ScrewsFebruary 22, 2021
K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, ActOctober 28, 2020
K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsJuly 23, 2020
K193295Parcus Knotless PEEK and PEEK CF Push-In Suture AnchorJanuary 23, 2020
K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipJanuary 16, 2020
K192964Parcus Synd-EZ SSNovember 22, 2019
K192824Parcus Knotless AP Suture AnchorsNovember 2, 2019
K191783Parcus Synd-EZ TiOctober 9, 2019
K190375Parcus ATLASApril 24, 2019
K183501Parcus Twist AP Suture AnchorsMarch 15, 2019
K183331Parcus GFS BTBFebruary 7, 2019
K170877Parcus SLiK Fix ScrewJune 2, 2017
K170327Parcus SLiK AnchorsMarch 30, 2017
K162198GFS UltimateNovember 18, 2016
K152711Parcus GFS NakedNovember 20, 2015
K133757GFS II STANDARD, GFS II LARGE, GFS MIMIFebruary 4, 2014