K240061
- 510(k) number
- K240061
- Device name
- TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System
- Applicant
- Smith & Nephew, Inc. TN · US
- Product code
- JDS — Nail, Fixation, Bone
- Decision date
- 2024-09-20
- Date received
- 2024-01-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K240061.pdf
Official FDA record: K240061
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.