510(k) K014156

CERASORB ORTHO by Curasan AG — Product Code MQV

K014156 is an FDA 510(k) premarket notification submitted by Curasan AG for the device "CERASORB ORTHO". The FDA issued a decision of Substantially Equivalent on March 18, 2002. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Curasan AG has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2002
Date Received
December 19, 2001
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