Howmedica Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
409
Inspections
0
Compliance Actions
0

Known Names

howmedica osteonics, howmedica

Recent 510(k) Clearances

K-NumberDeviceDate
K984251XIA SPINE SYSTEMFebruary 24, 1999
K984202HOWMEDICA HUMERAL INTERCALARY SYSTEMFebruary 5, 1999
K984305ZETA MULTIZONE LOCKING NAIL SYSTEMFebruary 1, 1999
K983885BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATESJanuary 29, 1999
K983528MICRO DYNAMIC MESHDecember 23, 1998
K983404TYPE 3 FEMORAL COMPONENTSDecember 22, 1998
K980926DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATIONDecember 16, 1998
K980925DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATIONDecember 16, 1998
K980626DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATIONDecember 11, 1998
K980632DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATIONDecember 11, 1998
K983419HOFFMANN II MIAMI POSTNovember 25, 1998
K982958ZETA MULTIZONE LOCKING NAIL SYSTEMNovember 20, 1998
K983358G/K SFN AND STN LOCKING NAILSNovember 18, 1998
K982873ZETA MULTIZONE SCN LOCKING NAILOctober 21, 1998
K982531HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEMOctober 16, 1998
K982670CONTEMPORARY ACETABULAR COMPONENTOctober 2, 1998
K982463EXTRACRANIAL RADIOTHERAPY SYSTEMSeptember 30, 1998
K982602RETROGRADE ROD SYSTEMSeptember 14, 1998
K982494BWM SPINE SYSTEMSeptember 8, 1998
K982248HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTHAugust 31, 1998