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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 Containing Single Approved Aminoglycoside
510(k) Number K234008
Device Name CERAMENT G
Applicant
BoneSupport AB
Scheelevagen 19 Ideon Science Park
SE-223 70
Lund,  SE
Applicant Contact Blerta Shuka
Correspondent
BoneSupport AB
Scheelevagen 19 Ideon Science Park
SE-223 70
Lund,  SE
Correspondent Contact Blerta Shuka
Classification Product Code
QRR  
Date Received12/19/2023
Decision Date 03/13/2024
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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