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FDA 510(k)

Boomerang™ Anterior Cervical Plate System

K-Number: K190227 · 2019-05-01

ApplicantChoicespine, LP
Decision Date2019-05-01
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Boomerang™ Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Choicespine, LP. It received FDA 510(k) clearance on 2019-05-01 under 510(k) 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. The listed applicant is Choicespine, LP. The 510(k) number is K190227.

When did Boomerang™ Anterior Cervical Plate System receive FDA 510(k) clearance?

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

Who is the listed applicant for Boomerang™ Anterior Cervical Plate System?

The FDA 510(k) record lists Choicespine, LP as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION

Other records listing Choicespine, LP as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183397ChoiceSpine Stealth Cervical Spacer SystemK182721Choice Spine Navigation SystemK183214Raven Lumbar Plate SystemK180519HARRIER-SA™ Lumbar Interbody SystemK172816TiGer Shark™ SystemK173215Choice Spine Laminoplasty™ Fixation System

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Related Devices (Code: KWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

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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