FDA 510(k)

Choice Spine Navigation System

K-Number: K182721 · 2019-01-08

Decision Date2019-01-08

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Choice Spine Navigation System is a medical device manufactured by Choicespine, LP. It received FDA 510(k) clearance on 2019-01-08 under approval number K182721. 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 Choice Spine Navigation System?

Choice Spine Navigation System is a medical device that received FDA 510(k) clearance on 2019-01-08. It is manufactured by Choicespine, LP. The 510(k) number is K182721.

When was Choice Spine Navigation System approved by the FDA?

Choice Spine Navigation System received FDA 510(k) clearance on 2019-01-08, under approval number K182721.

What company makes Choice Spine Navigation System?

Choice Spine Navigation System is manufactured by Choicespine, LP.

What is the FDA product code for Choice Spine Navigation System?

The FDA product code for Choice Spine 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 NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

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 Choicespine, LP

K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye) K160775Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems K153107Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine VEO Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System K171489Acapella Cervical Spacer System K170821ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System K170942The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems

View all 14 devices →

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.