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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Wrist, Hemi-, Ulnar
510(k) Number K982268
Device Name ULNAR HEAD IMPLANT
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 Number888.3810
Classification Product Code
KXE  
Date Received06/29/1998
Decision Date 12/04/1998
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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