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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 K990392
Device Name DEPUY ACE SPIDER PLATE
Applicant
Depuy Ace Medical Co.
2260 E. El Segundo Blvd.
El Segundo,  CA  90245
Applicant Contact KATHLEEN DRAGOVICH
Correspondent
Depuy Ace Medical Co.
2260 E. El Segundo Blvd.
El Segundo,  CA  90245
Correspondent Contact KATHLEEN DRAGOVICH
Regulation Number888.3030
Classification Product Code
HRS  
Date Received02/09/1999
Decision Date 03/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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