Spine Smith Holdings, LLC

FDA Regulatory Profile

Spine Smith Holdings, LLC appears in FDA public data with 1 recall, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2258-2013, Class II) was initiated on July 31, 2013. Its most recent 510(k) clearance was granted on January 10, 2020.

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