Core Essence Orthopaedics, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K111716KNOTLESS SUTURE FIXATION SYSTEMNovember 10, 2011
K101126PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPSDecember 2, 2010
K090128TAC-TITE (TM)March 19, 2009
K081060FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5December 24, 2008
K071477REVERTO 55 AND 37 SHAPE MEMORY STAPLESAugust 15, 2007
K071520RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502XAugust 10, 2007