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Danek Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
56
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K994122BONE GRAFT WASHER, MODEL 9090114 - 9090118February 18, 2000
K993810CD HORIZON SPINAL SYSTEMFebruary 3, 2000
K993855ATLANTIS ANTERIOR CERVICAL PLATE SYSTEMDecember 15, 1999
K991528MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTORMay 28, 1999
K990603MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEMMarch 10, 1999
K982875MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEMJanuary 19, 1999
K984522MODIFICATION OF TSRH SPINAL SYSTEMJanuary 6, 1999
K982154MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEMJuly 13, 1998
K970599TOWNLEY PEDICLE SCREW PLATING SYSTEMMarch 20, 1998
K943827SPINE FIXATIONFebruary 14, 1996
K943356INCLUSIVE ENDOSCOPEMay 10, 1995
K943676DANEKSCOPE OPTI-PROBENovember 21, 1994
K933205TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGONMay 4, 1994
K933242SOFAMOR ORTHOPAEDIC INSTRUMENTSJanuary 28, 1994
K911729DANEKSCOPE AND ACCESSORIESApril 5, 1993
K901692DANEK SPINALSCOPEFebruary 14, 1992
K904243TSRH VARIABLE ANGLE SACRAL SCREWJanuary 22, 1992
K913735SONGER(TM) CABLE SYSTEMNovember 18, 1991
K904520RAY SACRAL FIXATION SYSTEMOctober 25, 1991
K911307CROSSLINK PLATEOctober 24, 1991