K232566

NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System

510(k) number: K232566
Device name: NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System
Applicant: SeaSpine Orthopedics Corporation TX · US
Product code: NKB — Thoracolumbosacral Pedicle Screw System
Decision date: 2024-04-19
Date received: 2023-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Orthopedic

PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain

Also available from FDA: K232566.pdf

Official FDA record: K232566

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.