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FDA 510(k)

LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM

K-Number: K113366 · 2012-01-17

ApplicantPhygen, LLC
Decision Date2012-01-17
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LEUCADIA AUTOLOK 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 2012-01-17 under 510(k) number K113366. 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 AUTOLOK PEDICLE SCREW SYSTEM?

LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2012-01-17. The listed applicant is Phygen, LLC. The 510(k) number is K113366.

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

LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2012-01-17, under 510(k) number K113366.

Who is the listed applicant for LEUCADIA AUTOLOK 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 AUTOLOK PEDICLE SCREW SYSTEM?

The FDA product code for LEUCADIA AUTOLOK 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 SYSTEMK112931LEUCADIA(TM) MIS 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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