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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(k) Number K931690
Device Name SPOON PLATE
Applicant
ONYX MEDICAL CORP.
152 COLLINS ST.
MEMPHIS,  TN  38112
Applicant Contact LARAINE B GILMORE
Correspondent
ONYX MEDICAL CORP.
152 COLLINS ST.
MEMPHIS,  TN  38112
Correspondent Contact LARAINE B GILMORE
Regulation Number888.3030
Classification Product Code
HRS  
Date Received04/05/1993
Decision Date 06/07/1994
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
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