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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 K972622
Device Name STRAIGHT-IN BONE SCREW FIXATION SYSTEM
Applicant
Influence, Inc.
12037 Winesap Ter.
North Potomac,  MD  20878
Applicant Contact MARK D KRAMER
Correspondent
Influence, Inc.
12037 Winesap Ter.
North Potomac,  MD  20878
Correspondent Contact MARK D KRAMER
Regulation Number888.3040
Classification Product Code
MBI  
Date Received07/14/1997
Decision Date 10/09/1997
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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