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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 K933203
Device Name APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-POLY ACET COMP
Applicant
Intermedics Orthopedics
1300-C E. Anderson Ln.
Austin,  TX  78752
Applicant Contact JOANN RINGER
Correspondent
Intermedics Orthopedics
1300-C E. Anderson Ln.
Austin,  TX  78752
Correspondent Contact JOANN RINGER
Regulation Number888.3353
Classification Product Code
LZO  
Date Received07/01/1993
Decision Date 04/19/1994
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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