FDA 510(k)

Choice Spine Hawkeye Vertebral Body Replacement (VBR) System

K-Number: K171686 · 2017-09-15

Decision Date2017-09-15

Product CodeMQP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Choice Spine Hawkeye Vertebral Body Replacement (VBR) System is a medical device manufactured by Choicespine. It received FDA 510(k) clearance on 2017-09-15 under approval number K171686. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Choice Spine Hawkeye Vertebral Body Replacement (VBR) System?

Choice Spine Hawkeye Vertebral Body Replacement (VBR) System is a medical device that received FDA 510(k) clearance on 2017-09-15. It is manufactured by Choicespine. The 510(k) number is K171686.

When was Choice Spine Hawkeye Vertebral Body Replacement (VBR) System approved by the FDA?

Choice Spine Hawkeye Vertebral Body Replacement (VBR) System received FDA 510(k) clearance on 2017-09-15, under approval number K171686.

What company makes Choice Spine Hawkeye Vertebral Body Replacement (VBR) System?

Choice Spine Hawkeye Vertebral Body Replacement (VBR) System is manufactured by Choicespine.

What is the FDA product code for Choice Spine Hawkeye Vertebral Body Replacement (VBR) System?

The FDA product code for Choice Spine Hawkeye Vertebral Body Replacement (VBR) System is MQP.

Related Clinical Trials

NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT07601269 Replacement of the Native Mitral Valve Using the ReValve System RECRUITING NCT06414265 Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation RECRUITING NCT06608823 ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™ RECRUITING NCT03242642 Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation. RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026)

Other Devices by Choicespine

K171456Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) System

Related Devices (Code: MQP)

K172330Blustone Synergy Silica SystemBlustone Synergy K173125T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc. K172323Omnia Medical VBROmnia Medical, LLC K171704CAPRI Corpectomy Cage SystemK2m K162133VerteFIT Corpectomy Cage SystemLdr Spine USA, Inc.

Official Source

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