510(k) K141600
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