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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Threaded
510(k) Number K051740
Device Name TAPERED COMPRESSION PIN
Applicant
Nexa Orthopedics, Inc.
990 Park Center Dr., Suite H
Vista,  CA  92081
Applicant Contact LOUISE M FOCHT
Correspondent
Nexa Orthopedics, Inc.
990 Park Center Dr., Suite H
Vista,  CA  92081
Correspondent Contact LOUISE M FOCHT
Regulation Number888.3040
Classification Product Code
JDW  
Date Received06/28/2005
Decision Date 09/06/2005
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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