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Novosource, LLC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
4
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0483-2025Class IINovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip SysteSeptember 19, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K140701NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUGJune 27, 2014
K132158NOVOHIP TOTAL HIP SYSTEMFebruary 21, 2014
K131398NOVOKNEE TOTAL KNEE SYSTEMSeptember 16, 2013
K123339TK1 TOTAL KNEE SYSTEMApril 11, 2013