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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal
510(k) Number K833599
Device Name MODIFIED HPS HIP PROSTHESIS
Applicant
Depuy, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Depuy, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.3360
Classification Product Code
KWL  
Date Received10/12/1983
Decision Date 03/19/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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