K243905
- 510(k) number
- K243905
- Device name
- Stitch Cerclage Suture Tapes
- Applicant
- GM Dos Reis Industria e Comercio Ltda. BR
- Product code
- JDQ — Cerclage, Fixation
- Decision date
- 2025-08-14
- Date received
- 2024-12-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243905.pdf
Official FDA record: K243905
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.