510(k) K132050

NB3D BONE VOID FILLER by Pioneer Surgical Technology, Inc. — Product Code MQV

K132050 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology, Inc. for the device "NB3D BONE VOID FILLER". The FDA issued a decision of Substantially Equivalent on February 7, 2014. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Pioneer Surgical Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2014
Date Received
July 2, 2013
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