K241413
- 510(k) number
- K241413
- Device name
- sagAlign Lumbar Cage System (Various PNs)
- Applicant
- Acuity Surgical Devices, LLC TX · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-07-17
- Date received
- 2024-05-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.1 MB · U.S. public domain
Also available from FDA: K241413.pdf
Official FDA record: K241413
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.