510(k) K160995
K160995 is an FDA 510(k) premarket notification submitted by In2bones Sas for the device "NEOVIEW Plating System". The FDA issued a decision of Substantially Equivalent on June 10, 2016. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. In2bones Sas has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 2016
- Date Received
- April 8, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type