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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 K072710
Device Name NEXFIX COMPRESSION PIN
Applicant
Nexa Orthopedics, Inc.
11035 Roselle St.
San Diego,  CA  92121
Applicant Contact COREY WILSON-WIRTH
Correspondent
Nexa Orthopedics, Inc.
11035 Roselle St.
San Diego,  CA  92121
Correspondent Contact COREY WILSON-WIRTH
Regulation Number888.3040
Classification Product Code
JDW  
Date Received09/25/2007
Decision Date 11/08/2007
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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