510(k) K141600

NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT by Pioneer Surgical Technology, Inc. (Rti Surgical, I — Product Code MQV

K141600 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology, Inc. (Rti Surgical, I for the device "NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT". The FDA issued a decision of Substantially Equivalent on Oct 17, 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. (Rti Surgical, I has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 17, 2014
Date Received
Jun 16, 2014
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