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Scient'X

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
12
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K071261ISOBAR SEMI-RIGID DUAL DAMPENERApril 17, 2008
K062912SCIENT'X SPINAL SYSTEMFebruary 5, 2007
K052763STELLA CERVICAL PLATENovember 10, 2005
K052367SCIENT'X CEMENT RESTRICTOROctober 5, 2005
K050348CO VERTEBRAL BODY REPLACEMENTMay 27, 2005
K051063POLYAXIAL HEMISPHERICAL SPINAL SCREWSMay 23, 2005
K043001MX POLYAXIAL PEDICLE SCREWDecember 1, 2004
K042964MX MONOAXIAL PEDICLE SCREWNovember 22, 2004
K042317CERVICAL PLATESeptember 24, 2004
K040747ALADYN RIGID SPINE PLATEJune 17, 2004
K040454BIOFILL BONE VOID FILLERMay 7, 2004
K033109ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTSMarch 23, 2004