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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 K921111
Device Name S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD
Applicant
Joint Medical Products Corp.
860 Canal St.
Stamford,  CT  06902
Applicant Contact DEBRA L BING
Correspondent
Joint Medical Products Corp.
860 Canal St.
Stamford,  CT  06902
Correspondent Contact DEBRA L BING
Regulation Number888.3353
Classification Product Code
LZO  
Date Received03/09/1992
Decision Date 10/22/1992
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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