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SeaSpine Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
32
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1841-2014Class IIIntegra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used tMay 21, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K231654NorthStar OCT SystemAugust 3, 2023
K150469Integra Laminoplasty SystemMarch 23, 2015
K142488SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene December 18, 2014
K133418INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEMMay 1, 2014
K132859INTEGRA FACET FIXATION SYSTEMNovember 18, 2013
K121924INTEGRA INTERSPINOUS PROCESS SYSTEMSeptember 4, 2013
K130830INTEGRA LAMINOPLASTY SYSTEMMay 9, 2013
K122571MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEMDecember 12, 2012
K112206CARDIFF ANTERIOR CERVICAL PLATE SYSTEMJanuary 25, 2012
K111671SEASPINE MONOPOLAR PROBE SYSYEMDecember 28, 2011
K102026SEASPINE SPACER SYSTEMMay 12, 2011
K103297REDONDO-LJanuary 27, 2011
K092521ZUMA-CApril 13, 2010
K082309CAMBRIAApril 9, 2009
K083338CARDIFF ANTERIOR CERVICAL PLATE SYSTEMFebruary 2, 2009
K083089NEWPORT SPINAL SYSTEMJanuary 13, 2009
K082926ZUMA, MODEL 55-XXXX/56-XXXXDecember 22, 2008
K082310HOLLYWOOD, PACIFICA, REDONDO, VENTURANovember 10, 2008
K072729SIERRAApril 17, 2008
K080526SIERRA SYSTEMApril 16, 2008