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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Hemi-, Radial, Polymer
510(k) Number K002644
Device Name RADIAL 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 Number888.3170
Classification Product Code
KWI  
Date Received08/24/2000
Decision Date 11/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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