Integra Burlington MA, Inc.

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-1030-2013Class IIIntegra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cMarch 18, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K113570INTEGRA CUSA NXT INFERIOR FOWARD BONE TIPFebruary 22, 2012