Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Choice Spine Laminoplasty™ Fixation System

K-Number: K173215 · 2018-01-19

ApplicantChoicespine, LP
Decision Date2018-01-19
Product CodeNQW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Choice Spine Laminoplasty™ Fixation 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 2018-01-19 under 510(k) number K173215. The device is classified under product code NQW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Choice Spine Laminoplasty™ Fixation System?

Choice Spine Laminoplasty™ Fixation System is a medical device that received FDA 510(k) clearance on 2018-01-19. The listed applicant is Choicespine, LP. The 510(k) number is K173215.

When did Choice Spine Laminoplasty™ Fixation System receive FDA 510(k) clearance?

Choice Spine Laminoplasty™ Fixation System received FDA 510(k) clearance on 2018-01-19, under 510(k) number K173215.

Who is the listed applicant for Choice Spine Laminoplasty™ Fixation 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 Choice Spine Laminoplasty™ Fixation System?

The FDA product code for Choice Spine Laminoplasty™ Fixation System is NQW.

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.

K190227Boomerang™ Anterior Cervical Plate SystemK183397ChoiceSpine Stealth Cervical Spacer SystemK182721Choice Spine Navigation SystemK183214Raven Lumbar Plate SystemK180519HARRIER-SA™ Lumbar Interbody SystemK172816TiGer Shark™ System

View all 14 devices →

Related Devices (Code: NQW)

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.

K252930AQUA Laminoplasty SystemsZheJiang Decans Medical Devices Co., Ltd.K243137Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc.K242784Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLCK232471Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLCK231232Curiteva Laminoplasty SystemCuriteva, Inc.K212428Centerpiece Plate Fixation SystemMedtronic Sofamor Danek

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.

↑