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Osteomed, LLC

FDA Regulatory Profile

Summary

Total Recalls
15
510(k) Clearances
73
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2107-2023Class IIREF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, SterileMay 31, 2023
Z-2108-2023Class IIREF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, SterileMay 31, 2023
Z-0335-2022Class IIOsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMeOctober 28, 2021
Z-2189-2020Class IIOSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage: The productApril 2, 2020
Z-2188-2020Class IIOSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provideApril 2, 2020
Z-2186-2020Class IIOSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product Usage: The product proviApril 2, 2020
Z-2184-2020Class IIOSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product proviApril 2, 2020
Z-2182-2020Class IIOSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provApril 2, 2020
Z-2191-2020Class IIOSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Product Usage: The product prApril 2, 2020
Z-2185-2020Class IIOSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product proviApril 2, 2020
Z-2187-2020Class IIOSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usage: The product provideApril 2, 2020
Z-2180-2020Class IIOSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provApril 2, 2020
Z-2190-2020Class IIOSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage: The product prApril 2, 2020
Z-2181-2020Class IIOSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provApril 2, 2020
Z-2183-2020Class IIOSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The product providApril 2, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K212570OsteoPlan SystemFebruary 11, 2022
K203479ExtremiLOCK Lateral Ankle Fusion PlatesFebruary 24, 2021
K202105OsteoMed ExtremiFix Mini & Small System TrayOctober 29, 2020
K202680OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemOctober 15, 2020
K173391OsteoMed QuickFix Hybrid MMF Sterilization TrayMay 10, 2018
K162542OsteoMed PINNACLE DriverMay 19, 2017
K162544OsteoMed PINNACLE DriverApril 4, 2017
K163303OsteoMed ExtremiFix Mid and Large Screw SystemApril 4, 2017
K161041OsteoMed ExtremiLOCK Wrist Plating SystemMay 19, 2016
K152145OsteoMed ExtremiLOCK Wrist Plating SystemDecember 21, 2015
K151195OsteoMed IMF ScrewSeptember 21, 2015
K151021OsteoMed Cannulated Screw SystemJuly 15, 2015
K143338Argulated Locking PlatesApril 1, 2015
K140978OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEMDecember 18, 2014
K140283OSTEOMED EXTREMIFUSE SYSTEMFebruary 28, 2014
K133691EXTRIMILOCK ANKLE PLATING SYSTEMFebruary 24, 2014
K131851OSTEOMED NEURO RONGEURDecember 6, 2013
K1334371ST MTP PLATEDecember 2, 2013
K131445OSTEOMED EXTREMILOCK FOOT PLATING SYSTEMJune 18, 2013
K123885OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTORJune 3, 2013