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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple Driver
510(k) Number K962372
Device Name UROTAC BONE ANCHOR INSERTER
Applicant
Influence, Inc.
637 Steiner St.
San Francisco,  CA  94117
Applicant Contact PETER A BICK
Correspondent
Influence, Inc.
637 Steiner St.
San Francisco,  CA  94117
Correspondent Contact PETER A BICK
Regulation Number888.4540
Classification Product Code
HXJ  
Date Received06/19/1996
Decision Date 08/19/1996
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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