510(k) K230054

DSM Biomedical Calcium Phosphate Cement by Dsm Biomedical — Product Code MQV

K230054 is an FDA 510(k) premarket notification submitted by Dsm Biomedical for the device "DSM Biomedical Calcium Phosphate Cement". The FDA issued a decision of Substantially Equivalent on March 21, 2023. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Dsm Biomedical has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2023
Date Received
January 6, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type