Johnson & Johnson Orthopaedics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
22
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K931466PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRIDecember 6, 1994
K935452P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENTOctober 6, 1994
K940190ULTIMA UNIPOLAR MODULAR HEADSeptember 29, 1994
K933275P.F.C. CERAMIC HIP HEADSeptember 28, 1994
K932595ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTORSeptember 20, 1994
K931655P.F.C. BIPOLAR HIP SYSTEMJune 9, 1994
K933867UNIVERSAL INSET PATELLAJune 6, 1994
K935262P.F.C. TOTAL KNEE SYSTEM OVAL PATELLAJune 3, 1994
K931189P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACETFebruary 9, 1994
K931054TRICK MODULAR KNEE TIBIAL TRAY-POROUSJanuary 25, 1994
K924340P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERTJanuary 25, 1994
K930712P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAROctober 4, 1993
K924379ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEMFebruary 12, 1993
K924984SPECIALIST(R) WALKERFebruary 1, 1993
K924115ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPSNovember 24, 1992
K913629JOHNSON AND JOHNSON POWER SYSTEMNovember 13, 1991
K914439P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORALOctober 23, 1991
K910968P.F.C. UNICONDYLAR KNEE SYSTEMAugust 26, 1991
K904737GROSS HIP FEMORAL COMPONENTJuly 26, 1991
K910563P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIALMay 23, 1991