K241438
- 510(k) number
- K241438
- Device name
- Signus Tetris St; Signus Tetris R St
- Applicant
- Signus Medizintechnik GmbH DE
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-09-11
- Date received
- 2024-05-21
- 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: K241438.pdf
Official FDA record: K241438
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.