K251335
- 510(k) number
- K251335
- Device name
- Tera Lumbar Interbody Fusion System (Various PNs)
- Applicant
- Acuity Surgical Devices, LLC TX · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2025-06-02
- Date received
- 2025-04-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251335.pdf
Official FDA record: K251335
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.