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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Tendon, Passive
510(k) Number K964359
Device Name AVANTA ORTHOPAEDICS TENDON SPACER
Applicant
Avanta Orthopaedics, Inc.
9369 Carroll Park Dr., Suite A
San Diego,  CA  92121
Applicant Contact LOUISE M FOCHT
Correspondent
Avanta Orthopaedics, Inc.
9369 Carroll Park Dr., Suite A
San Diego,  CA  92121
Correspondent Contact LOUISE M FOCHT
Regulation Number888.3025
Classification Product Code
HXA  
Date Received11/01/1996
Decision Date 03/25/1997
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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