ACUTE Innovations, LLC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
5
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0852-2014Class IIThe ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws October 30, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K120163ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEMFebruary 17, 2012
K113318ACUTE INNOVATIONS MODULAR RIBLOC SYSTEMJanuary 12, 2012
K101170ACUTE INNOVATIONS STERNAL FIXATION SYSTEMSeptember 17, 2010
K081588RE-ZORB PLATING SYSTEMSeptember 3, 2008
K061206ACUTE BONE SCREWJune 19, 2006