K240181
- 510(k) number
- K240181
- Device name
- Clavicle and Scapula System
- Applicant
- Auxein Medical Pvt., Ltd. IN
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2024-10-09
- Date received
- 2024-01-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K240181.pdf
Official FDA record: K240181
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.