Surgtech, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K191192SurgTech GENOLL Total Knee SystemAugust 1, 2019
K173455SurgTech Bipolar Head SystemJune 14, 2018
K162125MALUC™ Total Hip Arthroplasty SystemMay 10, 2017
K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemApril 5, 2017
K161894SurgTech Trauma SystemFebruary 21, 2017
K152200SurgTech Interbody SystemMarch 25, 2016