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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 K181721
Device Name Ceracell Ortho Foam
Applicant
curasan AG
Lindigstrasse 4
kleinostheim,  DE 63801
Applicant Contact gregor thomas
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
san diego,  CA  92130
Correspondent Contact kevin a. thomas
Regulation Number888.3045
Classification Product Code
MQV  
Date Received06/29/2018
Decision Date 09/17/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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