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FDA 510(k)

Choice Spine Hawkeye Vertebral Body Replacement (VBR) System

K-Number: K183588 · 2019-02-22

ApplicantChoicespine
Decision Date2019-02-22
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 2019-02-22 under approval number K183588. 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 2019-02-22. It is manufactured by Choicespine. The 510(k) number is K183588.

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 2019-02-22, under approval number K183588.

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

K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems

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 K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine K171704CAPRI Corpectomy Cage SystemK2m

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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