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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 K831884
Device Name SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL
Applicant
Richards Manufacturer Co.
1450 Brooks Rd.
Memphis,  NE  38116
Applicant Contact Robert F. Games
Correspondent
Richards Manufacturer Co.
Memphis,  TN  38116
Correspondent Contact Robert F Games
Regulation Number888.3350
Classification Product Code
JDI  
Date Received06/13/1983
Decision Date 09/20/1983
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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