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Osteoimplant Technology, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
21
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K040685Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATEDJanuary 25, 2005
K041443OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEMNovember 16, 2004
K040225OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEMMay 6, 2004
K032729Z-SERIES MODULAR TOTAL HIP SYSTEMDecember 3, 2003
K030608OTI BONE CEMENT PLUGJune 12, 2003
K022779OTI UNICONDULAR INTERPOSITIONAL SPACERNovember 20, 2002
K021822R120 MODULAR TOTAL HIP SYSTEMJuly 23, 2002
K012762MJS POSTERIOR STABILIZED KNEE SYSTEMDecember 11, 2001
K011774R120 MODULAR TOTAL HIP SYSTEMSeptember 5, 2001
K003316OTI CERAMIC FEMORAL HEAD SYSTEMJanuary 19, 2001
K003199TRIAD II MODULAR TOTAL HIP SYSTEMJanuary 10, 2001
K000817OMEGA II MODULAR TOTAL HIP SYSTEMJune 8, 2000
K984227OMEGA II MODULAR TOTAL HIP SYSTEMApril 8, 1999
K990003J-SERIES OMEGA TOTAL HIP SYSTEMFebruary 24, 1999
K982886OTI MODULAR SHOULDER SYSTEMOctober 5, 1998
K982598OTI FEMORAL LOCK TOTAL HIP SYSTEMOctober 2, 1998
K980981OMEGA HA COATED TOTAL HIP SYSTEMMay 20, 1998
K974506LSF HA COATED TRIAD TOTAL HIP SYSTEMFebruary 27, 1998
K971020LSF TRIAD TOTAL HIP SYSTEMJune 18, 1997
K964924OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION)March 7, 1997