510(k) K090310

EQUIVABONE by Etex Corp. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2009
Date Received
February 6, 2009
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