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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 K010786
Device Name ULNAR HEAD IMPLANT
Applicant
AVANTA ORTHOPAEDICS, INC.
9369 CARROLL PARK DRIVE, STE.A
SAN DIEGO,  CA  92121
Applicant Contact LOUISE M FOCHT
Correspondent
AVANTA ORTHOPAEDICS, INC.
9369 CARROLL PARK DRIVE, STE.A
SAN DIEGO,  CA  92121
Correspondent Contact LOUISE M FOCHT
Regulation Number888.3810
Classification Product Code
KXE  
Date Received03/15/2001
Decision Date 04/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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