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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Acetabular, Hip, Prosthesis
510(k) Number K890450
Device Name INTERMEDICS APR(TM) II FEMORAL COMPONENT
Applicant
Intermedics Orthopedics
1300 E. Anderson Ln.
Bldg. C
Austin,  TX  78752
Applicant Contact THOMAS L CRAIG
Correspondent
Intermedics Orthopedics
1300 E. Anderson Ln.
Bldg. C
Austin,  TX  78752
Correspondent Contact THOMAS L CRAIG
Regulation Number878.3300
Classification Product Code
JDJ  
Date Received01/30/1989
Decision Date 08/09/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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