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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Limb Brace
510(k) Number K760002
Device Name KNEE AID
Applicant
Zimmer, Inc.
1831 Olive St. St. Louis,  MO 
Correspondent
Zimmer, Inc.
1831 Olive St. St. Louis,  MO 
Regulation Number890.3475
Classification Product Code
IQI  
Date Received05/26/1976
Decision Date 07/26/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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