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Osteonics Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
178
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K983657OSTEONICS SERIES 7000 AD TIBIAL TRAYApril 6, 2000
K980070OSTEONICS HA-COATED DEVICESJuly 23, 1999
K984375OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLYApril 30, 1999
K982798OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEMMarch 25, 1999
K984585OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVEFebruary 24, 1999
K990203OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMSFebruary 18, 1999
K990158OSTEONICS COMBINATION SCREW RING/BLOCKERFebruary 1, 1999
K984302OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWSDecember 18, 1998
K984353OSTEO 9MM IC TIBIAL NAILDecember 16, 1998
K983502OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEMDecember 16, 1998
K983382OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEMDecember 11, 1998
K983508OSTEO COMPRESSION CONDYLE SCREW SYSTEMDecember 7, 1998
K983226OSTEONICS X CEMENTED HIP STEM SERIESDecember 4, 1998
K983165OSTEO 4.0MM CANNULATED SCREW SYSTEMDecember 3, 1998
K983870OSTEONICS RESTORATION HA HIP STEMSDecember 2, 1998
K983339OSTEO DYNATROC PROXIMAL FEMORAL NAILOctober 27, 1998
K982936OSTEONICS EXTENDED FEMORAL BEARING HEADOctober 21, 1998
K983152OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWSSeptember 25, 1998
K974685OSTEONICS POLYETHYLENE ACETABULAR COMPONENTSSeptember 22, 1998
K982553OSTEO COMPRESSION HIP SCREW SYSTEMSeptember 22, 1998