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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, Biodegradable, Soft Tissue
510(k) Number K972783
Device Name BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR
Applicant
Bionx Implants, Inc.
555 13th St., NW
Washington,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Bionx Implants, Inc.
555 13th St., NW
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number888.3030
Classification Product Code
MAI  
Subsequent Product Code
HWC  
Date Received07/25/1997
Decision Date 04/14/1998
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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