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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, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K935990
Device Name F-220 PRESS-FIT FEMORAL HIP STEM SYSTEM
Applicant
Implex Corp.
80 Commerce Dr.
Allendale,  NJ  07401
Applicant Contact JAMES E MALAYTER
Correspondent
Implex Corp.
80 Commerce Dr.
Allendale,  NJ  07401
Correspondent Contact JAMES E MALAYTER
Regulation Number888.3353
Classification Product Code
MEH  
Date Received12/14/1993
Decision Date 07/13/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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