510(k) K210285
K210285 is an FDA 510(k) premarket notification submitted by Adaptable Ortho Innovations, LLC for the device "Adaptable Ortho Innovations Intramedullary Nail System". The FDA issued a decision of Substantially Equivalent on Mar 18, 2021. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 18, 2021
- Date Received
- Feb 2, 2021
- 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
- 510(k)