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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K200752

DB-Orthopedics · Dimensional Bioceramics, LLC · decided 2020-04-22 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
OsteoRepair-InjectDB-O-I5CCDIMENSIONAL BIOCERAMICS LLCMQV00850018568050
OsteoRepair-InjectDB-O-I3CCDIMENSIONAL BIOCERAMICS LLCMQV00850018568043
OsteoRepair-InjectDB-O-I20CCDIMENSIONAL BIOCERAMICS LLCMQV00850018568074
OsteoRepair-InjectDB-O-I10CCDIMENSIONAL BIOCERAMICS LLCMQV00850018568067
OsteoRepair-PasteDB-O-P10CCDIMENSIONAL BIOCERAMICS LLCMQV00850018568029
OsteoRepair-PasteDB-O-P20CCDIMENSIONAL BIOCERAMICS LLCMQV00850018568036
OsteoRepair-PasteDB-O-P5CCDIMENSIONAL BIOCERAMICS LLCMQV00850018568012
OsteoRepair-PasteDB-O-P3CCDIMENSIONAL BIOCERAMICS LLCMQV00850018568005