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FDA 510(k)

EOI SPINAL SYSTEM

K-Number: K083825 · 2009-03-19

ApplicantExpanding Orthopedics, Inc.
Decision Date2009-03-19
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EOI SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Expanding Orthopedics, Inc.. It received FDA 510(k) clearance on 2009-03-19 under 510(k) number K083825. 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 EOI SPINAL SYSTEM?

EOI SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2009-03-19. The listed applicant is Expanding Orthopedics, Inc.. The 510(k) number is K083825.

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

EOI SPINAL SYSTEM received FDA 510(k) clearance on 2009-03-19, under 510(k) number K083825.

Who is the listed applicant for EOI SPINAL SYSTEM?

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

What is the FDA product code for EOI SPINAL SYSTEM?

The FDA product code for EOI SPINAL SYSTEM is NKB.

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.

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Other records listing Expanding Orthopedics, Inc. 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.

K171519FLXfit™

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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