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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K070688
Device Name NEXFIX COMPRESSION STAPLE
Applicant
Nexa Orthopedics, Inc.
11035 Roselle St.
San Diego,  CA  92121
Applicant Contact LOUISE M FOCHT
Correspondent
Nexa Orthopedics, Inc.
11035 Roselle St.
San Diego,  CA  92121
Correspondent Contact LOUISE M FOCHT
Regulation Number888.3030
Classification Product Code
JDR  
Date Received03/12/2007
Decision Date 05/18/2007
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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