510(k) K201227
K201227 is an FDA 510(k) premarket notification submitted by Paragon 28, Inc. for the device "Phantom® Hindfoot TTC/TC Nail System". The FDA issued a decision of Substantially Equivalent on Jul 17, 2020. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Paragon 28, Inc. has 59 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 17, 2020
- Date Received
- May 6, 2020
- Clearance Type
- Special
- 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)