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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K993975
Device Name ABSOLUTE ABSORBABLE INTERFERENCE SCREW
Applicant
Innovasive Devices, Inc.
734 Forest St.
Marlboro,  MA  01752
Applicant Contact KATHLEEN MORAHAN
Correspondent
Innovasive Devices, Inc.
734 Forest St.
Marlboro,  MA  01752
Correspondent Contact KATHLEEN MORAHAN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/24/1999
Decision Date 12/20/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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