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Avanta Orthopaedics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K030881AVANTA CARPAL FUSION PLATING SYSTEMApril 10, 2003
K021859WRIST IMPLANTDecember 2, 2002
K023604MODIFICATION TO RADIAL HEAD IMPLANTNovember 27, 2002
K013629FINGER JOINT PROSTHESISJanuary 25, 2002
K011819RADIAL HEAD IMPLANTJune 19, 2001
K010847K'FIXJune 19, 2001
K003033SCAPHIX, STAPLE, FIXATION, BONEMay 30, 2001
K010786ULNAR HEAD IMPLANTApril 11, 2001
K002644RADIAL HEAD IMPLANTNovember 20, 2000
K990596DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEMApril 29, 1999
K982268ULNAR HEAD IMPLANTDecember 4, 1998
K982288RADIAL HEAD IMPLANTSeptember 8, 1998
K981715DISTAL RADIUS FRACTURE FIXATION PLATEJuly 29, 1998
K981716EXTERNAL FIXATIONJuly 17, 1998
K974911EXTERNAL FIXATORMarch 16, 1998
K965204AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANTJune 3, 1997
K964359AVANTA ORTHOPAEDICS TENDON SPACERMarch 25, 1997
K964381AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANTJanuary 22, 1997