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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 K260496
Device Name PearlBone™ Putty 1600
Applicant
Marine Biomedical
32 Blackman St.
Broome,  AU 6725
Applicant Contact Rolee Kumar
Correspondent
BioVera, Inc.
65 Promenade Saint Louis
Notre-Dame-De-L’Ile-Perrot,  CA J7W3J6
Correspondent Contact Robert Poggie
Regulation Number888.3045
Classification Product Code
MQV  
Date Received02/13/2026
Decision Date 11/02/2026
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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