510(k) K202858
K202858 is an FDA 510(k) premarket notification submitted by Conventus Orthopaedics, LLC for the device "Flex-ThreadTM Distal Fibula Intramedullary Nail System". The FDA issued a decision of Substantially Equivalent on January 22, 2021. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Conventus Orthopaedics, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 2021
- Date Received
- September 28, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rod, Fixation, Intramedullary And Accessories
- Device Class
- Class II
- Regulation Number
- 888.3020
- Review Panel
- OR
- Submission Type