510(k) K180204
K180204 is an FDA 510(k) premarket notification submitted by Visionare, LLC for the device "CranioMaxillofacial Fixation (CMF) System - CMF Visionare". The FDA issued a decision of Substantially Equivalent on Dec 28, 2018. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 28, 2018
- Date Received
- Jan 24, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type
- 510(k)