TRIGEN META-TAN Trochanteric Antegrade Nail
FDA 510(k) K243364 · Smith & Nephew, Inc.
510(k) numberK243364
Submission
- Device name
- TRIGEN META-TAN Trochanteric Antegrade Nail
- Applicant
- Smith & Nephew, Inc.
Memphis, TN, US - Received
- October 29, 2024
- Decision date
- December 9, 2024
- 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 TRIGEN META-TAN Trochanteric Antegrade Nail cleared by the FDA?
TRIGEN META-TAN Trochanteric Antegrade Nail (K243364) received a 510(k) decision of Substantially Equivalent on December 9, 2024, 41 days after the submission was received.
What is the product code of K243364?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.