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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 K241167
Device Name BioSphere Putty; BioSphere MIS Putty
Applicant
Synergy Biomedical
565 E Swedesford Rd.
Suite 310
Wayne,  PA  19087
Applicant Contact Kevin Booth
Correspondent
Bruder Consulting & Venture Group
268 Glen Pl.
Franklin Lakes,  NJ  07417
Correspondent Contact Scott Bruder
Regulation Number888.3045
Classification Product Code
MQV  
Date Received04/26/2024
Decision Date 12/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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