Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SeaSpine® NewPort™ Spinal System

K-Number: K161535 · 2016-09-08

ApplicantSeaSpine Orthopedics Corporation
Decision Date2016-09-08
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SeaSpine® NewPort™ Spinal System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2016-09-08 under approval number K161535. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SeaSpine® NewPort™ Spinal System?

SeaSpine® NewPort™ Spinal System is a medical device that received FDA 510(k) clearance on 2016-09-08. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K161535.

When was SeaSpine® NewPort™ Spinal System approved by the FDA?

SeaSpine® NewPort™ Spinal System received FDA 510(k) clearance on 2016-09-08, under approval number K161535.

What company makes SeaSpine® NewPort™ Spinal System?

SeaSpine® NewPort™ Spinal System is manufactured by SeaSpine Orthopedics Corporation.

What is the FDA product code for SeaSpine® NewPort™ Spinal System?

The FDA product code for SeaSpine® NewPort™ Spinal System is NKB.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06087445 A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia COMPLETED NCT07603258 Access-H20: Sensor-driven Smart Faucet Related Study COMPLETED

Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by SeaSpine Orthopedics Corporation

K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene; SeaSpine Cambria NanoMetalene K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone System K160902Mariner Pedicle Screw System K172926SeaSpine Vu cPOD, Zuma-C, Complete Cervical K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System

View all 66 devices →

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑