K242311
- 510(k) number
- K242311
- Device name
- EXPERT - Flexible Joint Fixation System
- Applicant
- GM Dos Reis Industria e Comercio Ltda. BR
- Product code
- HTN — Washer, Bolt Nut
- Decision date
- 2024-11-01
- Date received
- 2024-08-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K242311.pdf
Official FDA record: K242311
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.