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Orthomet, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
60
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K936310ORTHOMET HMC FEMORAL STEM COMPONENTJune 7, 1995
K945783ORTHOMET TITANIUM HYBRID FEMORAL STEMMay 30, 1995
K943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYApril 26, 1995
K944752ORTHOMET RESURFACING FEMORAL COMPONENTDecember 28, 1994
K930771PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEMNovember 30, 1994
K926334AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSEROctober 18, 1994
K931333ORTHOMET ACETABULAR CUP SYSTEMOctober 14, 1994
K932677AXIOM TOTAL KNEE SYSTEMOctober 14, 1994
K931678ORTHOMET LHMC FEMORAL STEMOctober 14, 1994
K923243PERFECTA TOTAL HIP SYSTEMJanuary 7, 1994
K925536HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEMJanuary 7, 1994
K924698AXIOM TOTAL KNEE SYSTEM, MODULAR TIBIAL TRAYOctober 27, 1993
K930595AXIOM TOTAL KNEE SYST, DUAL DOME ALL POLY TIB TRAYOctober 22, 1993
K924050TITANIUM NITRIDE COATED HEMI-HEAD COMPONENTAugust 25, 1993
K922847PERFECTA TOTAL HIP SYSTEMApril 6, 1993
K922733PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIPFebruary 9, 1993
K915190PERFECTA TOTAL HIP SYSTEM, HA COATEDDecember 24, 1992
K923583ORTHOMET PERFECTA TOTAL HIP SYSTEMDecember 7, 1992
K921836PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEADNovember 6, 1992
K923909CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTALNovember 4, 1992