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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 K963266
Device Name NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED
Applicant
Intermedics Orthopedics
9900 Spectrum Dr.
Austin,  TX  78717
Applicant Contact JACQUELYN A HUGHES
Correspondent
Intermedics Orthopedics
9900 Spectrum Dr.
Austin,  TX  78717
Correspondent Contact JACQUELYN A HUGHES
Regulation Number888.3358
Classification Product Code
LPH  
Date Received08/20/1996
Decision Date 10/15/1996
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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