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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 K190599
Device Name Aptis Medical Distal Radio Ulnar Joint Implant
Applicant
Aptis Medical, LLC
3602 Glenview Ave.
Glenview,  KY  40025
Applicant Contact Bryan Babb
Correspondent
ENMED lntemtional, Inc
PO Box 249
Del Mar,  CA  92014
Correspondent Contact Louise Focht
Regulation Number888.3810
Classification Product Code
KXE  
Date Received03/08/2019
Decision Date 05/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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