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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Hemi-, Radial, Polymer
510(k) Number K132735
Device Name AXIA RADIAL HEAD SYSTEM
Applicant
Imds (Innovative MEdical Device Systems) - Leis ME
2710 Discovery Dr., Suite 600
Co-Innovation Division
Orlando,  FL  32826
Applicant Contact ANDREW RYNEARSON
Correspondent
Imds (Innovative MEdical Device Systems) - Leis ME
2710 Discovery Dr., Suite 600
Co-Innovation Division
Orlando,  FL  32826
Correspondent Contact ANDREW RYNEARSON
Regulation Number888.3170
Classification Product Code
KWI  
Date Received09/03/2013
Decision Date 01/07/2014
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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