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FDA 510(k)

SeaSpine Navigation System

K-Number: K172517 · 2018-05-11

ApplicantSeaSpine Orthopedics Corporation
Decision Date2018-05-11
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SeaSpine Navigation System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2018-05-11 under approval number K172517. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SeaSpine Navigation System?

SeaSpine Navigation System is a medical device that received FDA 510(k) clearance on 2018-05-11. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K172517.

When was SeaSpine Navigation System approved by the FDA?

SeaSpine Navigation System received FDA 510(k) clearance on 2018-05-11, under approval number K172517.

What company makes SeaSpine Navigation System?

SeaSpine Navigation System is manufactured by SeaSpine Orthopedics Corporation.

What is the FDA product code for SeaSpine Navigation System?

The FDA product code for SeaSpine Navigation System is OLO.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT07271238 Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures RECRUITING NCT06895187 Catheter Ablation Using a Novel Navigation and Imaging System NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

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 K161535SeaSpine® NewPort™ Spinal System K160902Mariner Pedicle Screw System K172926SeaSpine Vu cPOD, Zuma-C, Complete Cervical

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Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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.

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