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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, smooth
510(k) Number K012125
Device Name OPUS MAGNUM ANCHOR & INSERTER
Applicant
OPUS MEDICAL, INC.
27127 CALLE ARROYO, SUITE 1924
SAN JUAN CAPISTRANO,  CA  92675
Applicant Contact MARK RITCHART
Correspondent
OPUS MEDICAL, INC.
27127 CALLE ARROYO, SUITE 1924
SAN JUAN CAPISTRANO,  CA  92675
Correspondent Contact MARK RITCHART
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Code
MBI  
Date Received07/06/2001
Decision Date 09/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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