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)

POLARIS SPINAL SYSTEM

K-Number: K103393 · 2011-02-02

ApplicantBiomet Spine
Decision Date2011-02-02
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POLARIS SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Spine. It received FDA 510(k) clearance on 2011-02-02 under 510(k) number K103393. 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 POLARIS SPINAL SYSTEM?

POLARIS SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2011-02-02. The listed applicant is Biomet Spine. The 510(k) number is K103393.

When did POLARIS SPINAL SYSTEM receive FDA 510(k) clearance?

POLARIS SPINAL SYSTEM received FDA 510(k) clearance on 2011-02-02, under 510(k) number K103393.

Who is the listed applicant for POLARIS SPINAL SYSTEM?

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

What is the FDA product code for POLARIS SPINAL SYSTEM?

The FDA product code for POLARIS SPINAL 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biomet Spine 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.

K152622Alta ACDF SystemK121130POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODSK112014ZYSTON STRAIGHT SPACER SYSTEMK093629SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEMK0910675.5 POLARIS SPINAL SYSTEMK082793INTERGRO DBM

View all 15 devices →

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.

K262149corra® cervical plating systemCarlsmed, Inc.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, LLC

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.

↑