K261406
- 510(k) number
- K261406
- Device name
- Versalock Proximal Tibial Plating System
- Applicant
- GM Dos Reis Industria e Comercio Ltda. BR
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2026-07-21
- Date received
- 2026-04-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K261406.pdf
Official FDA record: K261406
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.