510(k) K190321
K190321 is an FDA 510(k) premarket notification submitted by OrthoPediatrics Corp. for the device "Pediatric Nailing PlatformFemur". The FDA issued a decision of Substantially Equivalent on October 9, 2019. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. OrthoPediatrics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 2019
- Date Received
- February 13, 2019
- 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