Intramedullary Nail and Screws-Neonail
FDA 510(k) K141103 · Neoortho Produtos Ortopedicos S/A
510(k) numberK141103
Submission
- Device name
- Intramedullary Nail and Screws-Neonail
- Applicant
- Neoortho Produtos Ortopedicos S/A
San Diego, CA, US - Received
- April 29, 2014
- Decision date
- September 23, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Intramedullary Nail and Screws-Neonail cleared by the FDA?
Intramedullary Nail and Screws-Neonail (K141103) received a 510(k) decision of Substantially Equivalent on September 23, 2014, 147 days after the submission was received.
What is the product code of K141103?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.