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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, Cemented
510(k) Number K920003
Device Name DRG CEMETED STEM
Applicant
Intermedics Orthopedics
1300 E. Anderson Ln.
Bldg. C
Austin,  TX  78752
Correspondent
Intermedics Orthopedics
1300 E. Anderson Ln.
Bldg. C
Austin,  TX  78752
Regulation Number888.3350
Classification Product Code
JDI  
Date Received01/02/1992
Decision Date 03/13/1992
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
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