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Spine Smith Holdings, LLC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2258-2013Class IIVisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights July 31, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K193465CorticaLINK Spinal Fusion PlatformJanuary 10, 2020
K180807Celling Aspiration NeedleMay 24, 2018
K141537IN:C2 SPINAL FIXATION SYSTMENovember 25, 2014