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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 K240621
Device Name Morpheus® Moldable; Agilon® Moldable
Applicant
Biogennix, LLC
18007 Sky Park Cir.
Suite D
Irvine,  CA  92614
Applicant Contact Laura Jones
Correspondent
Bruder Consulting & Venture Group
268 Glen Pl.
Franklin Lakes,  NJ  07417
Correspondent Contact Scott Bruder
Regulation Number888.3045
Classification Product Code
MQV  
Date Received03/05/2024
Decision Date 04/30/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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