K243608
- 510(k) number
- K243608
- Device name
- TRIGEN Stable Lock Nut & Washer
- Applicant
- Smith & Nephew, Inc. TN · US
- Product code
- JDS — Nail, Fixation, Bone
- Decision date
- 2025-06-12
- Date received
- 2024-11-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243608.pdf
Official FDA record: K243608
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.