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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 K232315
Device Name Catalyst Bone Void Filler
Applicant
Ossdsign AB
Rapsgatan 23 A
Uppsala,  IE SE 754 50
Applicant Contact Jonas Aberg
Correspondent
Ossdsign AB
Rapsgatan 23 A
Uppsala,  SE SE 754 50
Correspondent Contact Jonas Aberg
Regulation Number888.3045
Classification Product Code
MQV  
Date Received08/02/2023
Decision Date 09/15/2023
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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