Amendia, Inc dba Spinal Elements

FDA Regulatory Profile

Amendia, Inc dba Spinal Elements appears in FDA public data with 1 recall, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0239-2018, Class II) was initiated on November 13, 2017.

Summary

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

Recent Recalls

NumberClassProductDate
Z-0239-2018Class IIPiranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate SystemNovember 13, 2017