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FDA 510(k)

LEUCADIA PEDICLE SCREW SYSTEM

K-Number: K103102 · 2011-02-08

ApplicantPhygen, LLC
Decision Date2011-02-08
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LEUCADIA 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 2011-02-08 under 510(k) number K103102. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEUCADIA PEDICLE SCREW SYSTEM?

LEUCADIA PEDICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2011-02-08. The listed applicant is Phygen, LLC. The 510(k) number is K103102.

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

LEUCADIA PEDICLE SCREW SYSTEM received FDA 510(k) clearance on 2011-02-08, under 510(k) number K103102.

Who is the listed applicant for LEUCADIA 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 PEDICLE SCREW SYSTEM?

The FDA product code for LEUCADIA PEDICLE SCREW SYSTEM is MNI.

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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 SYSTEMK112931LEUCADIA(TM) MIS PEDICLE SCREW SYSTEMK110679DEL MAR MONOAXIAL PEDICLE SCREW SYSTEMK110588LEUCADIA PEDICLE SCREW SYSTEMK103748LAGUNA PEDICLE SCREW SYSTEM

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Related Devices (Code: MNI)

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.

K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. , Ltd.K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.K160320PremierShandong Weigao Orthopaedic Device 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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