510(k) K163488
K163488 is an FDA 510(k) premarket notification submitted by Intrafuse, LLC for the device "Flex-Thread Clavicle Pin System". The FDA issued a decision of Substantially Equivalent on Mar 20, 2017. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Intrafuse, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 20, 2017
- Date Received
- Dec 12, 2016
- 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)