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FDA 510(k)

5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS

K-Number: K090203 · 2009-07-30

ApplicantEbi, L.P.
Decision Date2009-07-30
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Ebi, L.P.. It received FDA 510(k) clearance on 2009-07-30 under 510(k) number K090203. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS?

5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS is a medical device that received FDA 510(k) clearance on 2009-07-30. The listed applicant is Ebi, L.P.. The 510(k) number is K090203.

When did 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS receive FDA 510(k) clearance?

5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS received FDA 510(k) clearance on 2009-07-30, under 510(k) number K090203.

Who is the listed applicant for 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS?

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

What is the FDA product code for 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS?

The FDA product code for 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS is NKB.

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Other records listing Ebi, L.P. 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.

K100438POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEMK100220POLARIS SPINAL SYSTEMK093880PEANUT GROWTH CONTROL PLATING SYSTEMK092574ESL SPINAL SYSTEMK093057BIOMET VISION FOOTRING SYSTEMK092336C-THRU SPINAL SYSTEM

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Related Devices (Code: NKB)

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.

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

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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