EBI Patient Care, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2 (2 Class I)
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2119-2017Class I10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the April 20, 2017
Z-2118-2017Class I10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increaApril 20, 2017