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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/Polymer, Porous Uncemented
510(k) Number K970300
Device Name NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI
Applicant
Intermedics Orthopedics
9900 Spectrum Dr.
Austin,  TX  78717
Applicant Contact LORI KLEINSCHRIDT HOLDER
Correspondent
Intermedics Orthopedics
9900 Spectrum Dr.
Austin,  TX  78717
Correspondent Contact LORI KLEINSCHRIDT HOLDER
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
MEH  
Date Received01/24/1997
Decision Date 07/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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