510(k) K173362

DSM Biomedical Calcium Phosphate Cement by Kensey Nash Corporation Dba Dsm Biomedical — Product Code MQV

K173362 is an FDA 510(k) premarket notification submitted by Kensey Nash Corporation Dba Dsm Biomedical for the device "DSM Biomedical Calcium Phosphate Cement". The FDA issued a decision of Substantially Equivalent on April 3, 2018. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Kensey Nash Corporation Dba Dsm Biomedical has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2018
Date Received
October 26, 2017
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