K241466
- 510(k) number
- K241466
- Device name
- Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System
- Applicant
- SeaSpine Orthopedics Corporation CA · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-06-20
- Date received
- 2024-05-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K241466.pdf
Official FDA record: K241466
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.