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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 K970292
Device Name IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW
Applicant
INFLUENCE, INC.
601 MONTGOMERY ST., SUITE 845
SAN FRANCISCO,  CA  94111
Applicant Contact PETER BICK
Correspondent
INFLUENCE, INC.
601 MONTGOMERY ST., SUITE 845
SAN FRANCISCO,  CA  94111
Correspondent Contact PETER BICK
Regulation Number888.3040
Classification Product Code
MBI  
Date Received01/24/1997
Decision Date 04/23/1997
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
Recalls CDRH Recalls
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