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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, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K935185
Device Name MORPHOMETRIC TOTAL HIP PROSTHESIS
Applicant
LANDOS, INC.
301 LINDENWOOD DR.
SUITE ONE
MALVERN,  PA  19355
Applicant Contact HENRY P FERRET
Correspondent
LANDOS, INC.
301 LINDENWOOD DR.
SUITE ONE
MALVERN,  PA  19355
Correspondent Contact HENRY P FERRET
Regulation Number888.3353
Classification Product Code
LZO  
Date Received10/26/1993
Decision Date 06/16/1994
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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