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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 K980334
Device Name INNOVASIVE 10MM LINX HT LIGAMENT FASTENER
Applicant
Innovasive Devices, Inc.
734 Forest St.
Marlboro,  MA  01752
Applicant Contact STEPHEN PAGE
Correspondent
Innovasive Devices, Inc.
734 Forest St.
Marlboro,  MA  01752
Correspondent Contact STEPHEN PAGE
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HRX  
Date Received01/28/1998
Decision Date 04/27/1998
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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