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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Toe, Constrained, Polymer
510(k) Number K023086
FOIA Releasable 510(k) K023086
Device Name CLASSIC GREAT TOE IMPLANT
Applicant
Nexa Orthopedics, Inc.
990 Park Center Dr., Suite H
Vista,  CA  92083
Applicant Contact LOUISE M FOCHT
Correspondent
Nexa Orthopedics, Inc.
990 Park Center Dr., Suite H
Vista,  CA  92083
Correspondent Contact LOUISE M FOCHT
Regulation Number888.3720
Classification Product Code
KWH  
Date Received09/17/2002
Decision Date 10/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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