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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 K042914
Device Name OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE
Applicant
OPUS MEDICAL, INC.
27127 CALLE ARROYO, SUITE 1924
SAN JUAN CAPISTRANO,  CA  92675
Applicant Contact LAURA N KASPEROWICZ
Correspondent
OPUS MEDICAL, INC.
27127 CALLE ARROYO, SUITE 1924
SAN JUAN CAPISTRANO,  CA  92675
Correspondent Contact LAURA N KASPEROWICZ
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HTY  
Date Received10/21/2004
Decision Date 11/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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