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FDA 510(k)

LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM

K-Number: K112931 · 2011-11-02

ApplicantPhygen, LLC
Decision Date2011-11-02
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Phygen, LLC. It received FDA 510(k) clearance on 2011-11-02 under 510(k) number K112931. 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 LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM?

LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2011-11-02. The listed applicant is Phygen, LLC. The 510(k) number is K112931.

When did LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM receive FDA 510(k) clearance?

LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2011-11-02, under 510(k) number K112931.

Who is the listed applicant for LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM?

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

What is the FDA product code for LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM?

The FDA product code for LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM is NKB.

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Other records listing Phygen, LLC 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.

K120355LEUCADIA 4.5 MM PEDICLE SCREW SYSTEMK113366LEUCADIA AUTOLOK PEDICLE SCREW SYSTEMK110679DEL MAR MONOAXIAL PEDICLE SCREW SYSTEMK110588LEUCADIA PEDICLE SCREW SYSTEMK103748LAGUNA PEDICLE SCREW SYSTEMK103102LEUCADIA PEDICLE SCREW 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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