K233509
- 510(k) number
- K233509
- Device name
- Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System
- Applicant
- Zavation Medical Products, LLC MS · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-04-10
- Date received
- 2023-10-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K233509.pdf
Official FDA record: K233509
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.