Biodynamic Technologies, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
30
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K990436ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEMMarch 31, 1999
K990481ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEMMarch 17, 1999
K990513ULTIMAX CORTICAL BONE SCREWSMarch 17, 1999
K981230ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEMJune 1, 1998
K980102BTI HUMERAL INTRAMEDULLARY ROD SYSTEMApril 3, 1998
K974756BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWSMarch 12, 1998
K972403BTI CORTICAL BONE SCREWSAugust 29, 1997
K970897BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEMApril 21, 1997
K962706EZ-FIX CANNULATED SCREW SYSTEMNovember 13, 1996
K962987EZ-FIX SMALL CANNULATED SCREW SYSTEMNovember 4, 1996
K962846EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEMOctober 23, 1996
K962552EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEMSeptember 25, 1996
K962553EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEMAugust 28, 1996
K954838EZ FIXJanuary 24, 1996
K935593ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEMOctober 14, 1994
K932918TOTAL KNEE KITSeptember 1, 1994
K926216BONE CEMENT RESTRICTORMarch 22, 1994
K935646FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEMMarch 9, 1994
K931540UNIVERSAL BONE CEMENT KITJanuary 27, 1994
K924323THE UNIVERSAL BONE CEMENT RESISTORFebruary 12, 1993