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Encore Orthopedics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
85
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K0329053DKNEE POROUS COATED FEMORAL COMPONENTJuly 6, 2004
K0201143D KNEEJuly 12, 2002
K020741UNICONDYLAR KNEEJune 4, 2002
K020236MODIFICATION TO PASS SPINAL SYSTEMFebruary 14, 2002
K020170KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UPFebruary 11, 2002
K013490CEMENTED CALCAR HIP SYSTEMJanuary 17, 2002
K013442PASS SPINAL SYSTEMJanuary 15, 2002
K003324PLASMA SPRAYED SHOULDERDecember 6, 2001
K013431PASS SPINAL SYSTEMNovember 15, 2001
K013191PASS SPINAL SYSTEMOctober 24, 2001
K011856RADIOGRAPHIC MARKERSAugust 22, 2001
K012175PASS SPINAL SYSTEMJuly 31, 2001
K003250FMP METAL/METAL ACETABULAR INSERTJanuary 25, 2001
K002941ACETABULAR PLATESDecember 4, 2000
K002959MODIFICATION TO ISOBAR SPINAL SYSTEMOctober 16, 2000
K001847ANTERIOR CERVICAL PLATE SYSTEMAugust 24, 2000
K001024PASS SPINAL SYSTEMMay 23, 2000
K000590LATERAL PIVOT INSERTMay 11, 2000
K000521KEYSTONE HIPMay 10, 2000
K993841CEMSTOP CEMENT RESTRICTORMay 4, 2000