K253420
- 510(k) number
- K253420
- Device name
- Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy
- Applicant
- SeaSpine Orthopedics Corporation CA · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2026-07-01
- Date received
- 2025-10-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 4.9 MB · U.S. public domain
Also available from FDA: K253420.pdf
Official FDA record: K253420
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.