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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 K982155
Device Name SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM
Applicant
Influence, Inc.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Influence, Inc.
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received06/18/1998
Decision Date 08/31/1998
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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