510(k) K141103
K141103 is an FDA 510(k) premarket notification submitted by Neoortho Produtos Ortopedicos S/A for the device "INTRAMEDULLARY NAIL AND SCREWS-NEONAIL". The FDA issued a decision of Substantially Equivalent on Sep 23, 2014. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Neoortho Produtos Ortopedicos S/A has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 23, 2014
- Date Received
- Apr 29, 2014
- 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)