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Ascension Orthopedics, Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
29
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0794-2019Class IIIAscension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WWNovember 16, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K233674Freedom Wrist Arthroplasty SystemMay 30, 2024
K233670Ascension Silicone MCP; Ascension Silicone PIPDecember 14, 2023
K182878Integra Salto Total Ankle SystemDecember 18, 2018
K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemJuly 14, 2017
K160830Integra External Fixation SystemJuly 6, 2016
K152047INTEGRA TITAN Modular Total Shoulder System Fin-Lock GlenoidDecember 23, 2015
K152527Integra DigiFuse Cannulated Intramedullary Fusion SystemOctober 29, 2015
K151459Integra Total Ankle Replacement SystemAugust 31, 2015
K142413TITAN Modular Total Shoulder SystemNovember 14, 2014
K121826INTEGRA PROXIMAL HUMERAL PLATE SYSTEMFebruary 13, 2013
K110700ASCENSION ATLAS HUMERAL PLATING SYSTEMDecember 6, 2011
K102549THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTYDecember 21, 2010
K100448ASCENSION MODULAR TOTAL SHOULDER SYSTEMAugust 30, 2010
K100502ASCENSION TOTAL PLATE SYSTEMAugust 2, 2010
K100925ASCENSION ANKLE FUSION NAIL SYSTEMJuly 12, 2010
K100176ASCENSION ANKLE FUSION PLATE SYSTEMJune 16, 2010
K092047ASCENSION METAL GREAT TOE SYSTEMJanuary 14, 2010
K092440ASCENSION CANNULATED SCREW SYSTEMNovember 5, 2009
K082231ASCENSION SILICONE PIPJanuary 12, 2009
K080997ASCENSION PYROCARBON LUNATEJune 17, 2008