New Era Orthopaedics, LLc

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-2604-2018Class IIModera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07February 13, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K141253NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEMJanuary 9, 2015