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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement Obturator
510(k) Number K852449
Device Name HOWMEDICA HIP SYS DISTAL CENTRALIZING SPACER
Applicant
Howmedica Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Applicant Contact CHARLES H LAWYER
Correspondent
Howmedica Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Correspondent Contact CHARLES H LAWYER
Regulation Number878.3300
Classification Product Code
LZN  
Subsequent Product Code
JDI  
Date Received06/10/1985
Decision Date 08/12/1985
Decision Substantially Equivalent (SESE)
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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