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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
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