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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 K920955
Device Name APR(R) HIP SYST & NATURAL-HIP(R) FOR UNCEMENT USE
Applicant
Intermedics Orthopedics
1300 E. Anderson Ln.
Bldg. C
Austin,  TX  78752
Applicant Contact WEBB
Correspondent
Intermedics Orthopedics
1300 E. Anderson Ln.
Bldg. C
Austin,  TX  78752
Correspondent Contact WEBB
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received02/26/1992
Decision Date 02/09/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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