K240388
- 510(k) number
- K240388
- Device name
- Osteotomy Truss System (OTS)
- Applicant
- 4Web Medical, Inc. TX · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2024-11-01
- Date received
- 2024-02-08
- 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: K240388.pdf
Official FDA record: K240388
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.