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Ascension Orthopedic

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K140463INTEGRA EXTERNAL FIXATION SYSTEMOctober 10, 2014
K131360INTEGRA TITANIUM BONE WEDGEAugust 7, 2013
K130050TITAN REVERSE SHOULDER SYSTEMJune 18, 2013
K112438TITAN MODULAR TOTAL SHOULDER SYSTEMApril 11, 2012
K112481FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANTApril 9, 2012
K112278ASCENSION NUGRIP CMC IMPLANTNovember 4, 2011
K111799NUGAIT(TM) SUBTALAR IMPLANT SYSTEMAugust 19, 2011