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Spineworks, LLC

FDA Regulatory Profile

Spineworks, LLC appears in FDA public data with 0 recalls, 4 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on April 11, 2014.

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K133340SPINEWORKS ANTERIOR LUMBAR DEVICEApril 11, 2014
K111166A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)September 8, 2011
K081331FIXXSURE CROSS LINKJuly 23, 2008
K042600STANSION MATRIXFebruary 18, 2005

FDA data resources