FDA 510(k)

Boomerang Anterior Cervical Plate System

K-Number: K190227 · 2019-05-01

Decision Date2019-05-01

Product CodeKWQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Boomerang Anterior Cervical Plate System is a medical device manufactured by Choicespine, LP. It received FDA 510(k) clearance on 2019-05-01 under approval number K190227. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Boomerang Anterior Cervical Plate System?

Boomerang Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2019-05-01. It is manufactured by Choicespine, LP. The 510(k) number is K190227.

When was Boomerang Anterior Cervical Plate System approved by the FDA?

Boomerang Anterior Cervical Plate System received FDA 510(k) clearance on 2019-05-01, under approval number K190227.

What company makes Boomerang Anterior Cervical Plate System?

Boomerang Anterior Cervical Plate System is manufactured by Choicespine, LP.

What is the FDA product code for Boomerang Anterior Cervical Plate System?

The FDA product code for Boomerang Anterior Cervical Plate System is KWQ.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING NCT06977035 Nerve Conduction Study for Assessment of Peripheral Neuropathy in Rheumatoid Arthritis Patients on the Janus Kinase Inhibitor Baricitinib RECRUITING

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: KWQ)

K160982SphynxEden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, 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.