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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 K251556
Device Name Device 300423 Granules
Applicant
Geistlich Pharma AG
Bahnhofstrasse 40
Wolhusen,  CH 6110
Applicant Contact Jan Van der Ploeg
Correspondent
Gxpartners, LLC
7626 Prairie View Ln.
Indianapolis,  IN  46256
Correspondent Contact Gretchen Upton
Regulation Number888.3045
Classification Product Code
MQV  
Date Received05/21/2025
Decision Date 07/17/2025
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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