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Spinal Concepts, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
33
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K051000FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICEMay 19, 2005
K050706HARMONY PORT SYSTEM, MODEL 1907 SERIESApril 15, 2005
K040096SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEMJuly 1, 2004
K033663SPINAL CONCEPTS INC. CODAMay 27, 2004
K033517SPINAL CONCEPTS INC. CADENCE AND TRAXISFebruary 18, 2004
K031855SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEMSeptember 17, 2003
K031985SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEMSeptember 11, 2003
K031318TRAXIS CEMENT RESTRICTORAugust 22, 2003
K031672SPINAL CONCEPTS, INC. INFIX SYSTEMAugust 7, 2003
K031837MODIFICATION TO FORTITUDE CEMENT RESTRICTORJuly 24, 2003
K030087SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEMJuly 17, 2003
K031914SPINAL CONCEPTS, INC. CADENCE AND FORTITUDEJuly 12, 2003
K030625SPINAL CONCEPTS INC. PATHFINDERMarch 28, 2003
K024326SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEMJanuary 23, 2003
K023647CADENCE PEEK CEMEENT RESTRICTORNovember 27, 2002
K023644MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEMNovember 25, 2002
K021564INCOMPASS SPINAL FIXATION SYSTEMOctober 25, 2002
K021719FORTITUDE CEMENT RESTRICTORAugust 15, 2002
K022218CADENCE CEMENT RESTRICTORAugust 12, 2002
K021009OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEMJune 18, 2002