611 Ankle Fusion Nail
FDA 510(k) K130051 · Tornier S.A.S.
510(k) numberK130051
Submission
- Device name
- 611 Ankle Fusion Nail
- Applicant
- Tornier S.A.S.
Monbonnot Saint Martin, FR - Received
- January 9, 2013
- Decision date
- July 15, 2013
- 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 611 Ankle Fusion Nail cleared by the FDA?
611 Ankle Fusion Nail (K130051) received a 510(k) decision of Substantially Equivalent on July 15, 2013, 187 days after the submission was received.
What is the product code of K130051?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.