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FDA 510(k)

ATHENA PEDICLE SCREW SYSTEM

K-Number: K110046 · 2011-12-07

ApplicantRoyal Oak Medical Devices
Decision Date2011-12-07
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ATHENA PEDICLE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Royal Oak Medical Devices. It received FDA 510(k) clearance on 2011-12-07 under 510(k) number K110046. 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 ATHENA PEDICLE SCREW SYSTEM?

ATHENA PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2011-12-07. The listed applicant is Royal Oak Medical Devices. The 510(k) number is K110046.

When did ATHENA PEDICLE SCREW SYSTEM receive FDA 510(k) clearance?

ATHENA PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2011-12-07, under 510(k) number K110046.

Who is the listed applicant for ATHENA PEDICLE SCREW SYSTEM?

The FDA 510(k) record lists Royal Oak Medical Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATHENA PEDICLE SCREW SYSTEM?

The FDA product code for ATHENA PEDICLE SCREW 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 Royal Oak Medical Devices 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.

K110177HELENA SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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