Bioretec, Ltd.

FDA Regulatory Profile

Bioretec, Ltd. appears in FDA public data with 0 recalls, 9 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on March 29, 2023.

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
DEN220030RemeOs™ Screw LAG SolidMarch 29, 2023
K133950ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)January 22, 2014
K130716BIORETEC ACTIVASCREW INTERFERENCEAugust 28, 2013
K080879ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTMJune 24, 2008
K081392BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPINJune 18, 2008
K072848ACTIVASCREWNovember 2, 2007
K071863ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)August 31, 2007
K062980ACTIVASCREWNovember 22, 2006
K061164ACTIVAPINJuly 6, 2006