K240830
- 510(k) number
- K240830
- Device name
- Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System
- Applicant
- Orthofix Medical, Inc. TX · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-06-20
- Date received
- 2024-03-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K240830.pdf
Official FDA record: K240830
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.