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Lanx, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
36
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0400-2014Class IILANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("DriverNovember 4, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K131547LANX FUSION SYSTEMJuly 12, 2013
K131156LANX SPINAL FIXATION SYSTEMMay 24, 2013
K123767LANX FUSION SYSTEM- SAMarch 18, 2013
K121316LANX SPINAL FIZATION SYSTEMSeptember 10, 2012
K122145LANX SPINAL FIXATION SYSTEMAugust 17, 2012
K121940LANX SPINAL FIXATION SYSTEMAugust 2, 2012
K120399LANX SPINAL FIXATION SYSTEMMarch 9, 2012
K113434LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)December 19, 2011
K112388LANX CERVICAL SADecember 16, 2011
K103091LANX SPINAL FIXATION SYSTEMApril 15, 2011
K103237LANX SPINAL SYSTEMMarch 25, 2011
K103666LANX LATERALMarch 23, 2011
K103660LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEMFebruary 28, 2011
K102738LANX FUSION SYSTEMFebruary 10, 2011
K103040LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)February 8, 2011
K100888MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEMNovember 15, 2010
K101364LANX FACET SCREW SYSTEMAugust 16, 2010
K100935LANX SPINAL FIXATION SYSTEMAugust 6, 2010
K100191LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)April 15, 2010
K092765LANX ANTERIOR PLATING SYSTEMApril 7, 2010