Signal Medical Corporation

FDA Regulatory Profile

Signal Medical Corporation appears in FDA public data with 3 recalls, 2 510(k) clearances, 10 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-1834-2017, Class II) was initiated on February 20, 2017. Its most recent 510(k) clearance was granted on June 10, 2021.

Summary

Total Recalls
3
510(k) Clearances
2
Inspections
10
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-1834-2017Class IISoft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090February 20, 2017
Z-0111-2015Class IISymmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component isSeptember 30, 2014
Z-0109-2015Class IIMicroseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTMSeptember 23, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K203779Symmetric Total Knee SystemJune 10, 2021
K080199SYMMETRIC TOTAL KNEE SYSTEMJuly 3, 2008