K261159
- 510(k) number
- K261159
- Device name
- Exceed® Biplanar Expandable Interbody System
- Applicant
- Spine Wave, Inc. CT · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2026-05-29
- Date received
- 2026-04-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K261159.pdf
Official FDA record: K261159
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.