K231684
- 510(k) number
- K231684
- Device name
- Quick - Radius Disposable Set
- Applicant
- GM Dos Reis Industria e Comercio Ltda. BR
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2024-01-12
- Date received
- 2023-06-09
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K231684.pdf
Official FDA record: K231684
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.