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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, External Fixator (With Metallic Invasive Components)
510(k) Number K140649
Device Name VECTRIX EXTERNAL FIXATOR
Applicant
3D MEDICAL CONCEPTS, LLC
1061 MORGAN PARK RD.
Pelham,  AL  35242
Applicant Contact BEVERLY LAIRD
Correspondent
3D MEDICAL CONCEPTS, LLC
1061 MORGAN PARK RD.
Pelham,  AL  35242
Correspondent Contact BEVERLY LAIRD
Regulation Number888.3040
Classification Product Code
NDK  
Date Received03/13/2014
Decision Date 12/29/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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