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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 K121682
Device Name ACTIVE SCREW BONE SCREW
Applicant
INTELLIGENT IMPLANT SYSTEMS, LLC
3300 INTERNATIONAL AIRPORT
DRIVE SUITE 1100
CHARLOTTE,  NC  28208
Applicant Contact MICHAEL J NUTT
Correspondent
INTELLIGENT IMPLANT SYSTEMS, LLC
3300 INTERNATIONAL AIRPORT
DRIVE SUITE 1100
CHARLOTTE,  NC  28208
Correspondent Contact MICHAEL J NUTT
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/07/2012
Decision Date 10/04/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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