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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K173424
Device Name BioSphere Flex
Applicant
Synergy Biomedical
100 Springhouse Dr.
Suite 108
Collegeville,  PA  19426
Applicant Contact Mark Borden
Correspondent
Hogan Lovells US LLP
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact Randy Prebula
Regulation Number888.3045
Classification Product Code
MQV  
Date Received11/01/2017
Decision Date 09/12/2018
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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