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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name fastener, fixation, nondegradable, soft tissue
510(k) Number K020172
Device Name OPUS MAGNUM ANCHOR & INSTRUMENT SET
Applicant
OPUS MEDICAL, INC.
27127 CALLE ARROYO, SUITE 1924
SAN JUAN CAPISTRANO,  CA  92675
Applicant Contact JIM HART
Correspondent
OPUS MEDICAL, INC.
27127 CALLE ARROYO, SUITE 1924
SAN JUAN CAPISTRANO,  CA  92675
Correspondent Contact JIM HART
Regulation Number888.3040
Classification Product Code
MBI  
Date Received01/17/2002
Decision Date 07/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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