510(k) K161996
K161996 is an FDA 510(k) premarket notification submitted by Amend Surgical, Inc. for the device "0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE". The FDA issued a decision of Substantially Equivalent on Feb 16, 2017. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 16, 2017
- Date Received
- Jul 19, 2016
- 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
- 510(k)