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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 K945516
Device Name NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM
Applicant
Intermedics Orthopedics
1300 E. Anderson Ln.
Bldg. C
Austin,  TX  78752
Applicant Contact JOANN RINGER-KUHNE
Correspondent
Intermedics Orthopedics
1300 E. Anderson Ln.
Bldg. C
Austin,  TX  78752
Correspondent Contact JOANN RINGER-KUHNE
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
LPH  
Date Received11/09/1994
Decision Date 02/14/1995
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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