510(k) K202914
K202914 is an FDA 510(k) premarket notification submitted by Fusion Innovations, LLC for the device "SternaFuse Fixation System". The FDA issued a decision of Substantially Equivalent on Jan 26, 2022. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Fusion Innovations, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 26, 2022
- Date Received
- Sep 29, 2020
- 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