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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 K153182
Device Name SELF- COMPRESSIVE SCREW
Applicant
Neosteo
2 Rue Robert Schuman
Reze,  FR 44 400
Applicant Contact JD WEBB
Correspondent
The OrthoMedix Group, Inc.
1001 Oakwood Blvd.
Round Rock,  TX  78681
Correspondent Contact JD WEBB
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/03/2015
Decision Date 11/25/2015
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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