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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, Hemi-, Femoral, Metal
510(k) Number K800207
Device Name UHR UNIVERSAL6HIP REPLACEMENT
Applicant
OSTEONICS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
OSTEONICS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.3360
Classification Product Code
KWL  
Date Received01/30/1980
Decision Date 02/11/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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