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FDA 510(k)

MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS

K-Number: K130073 · 2013-12-16

ApplicantMikron Makina Sanayi VE Ticaret Ltd. Sti.
Decision Date2013-12-16
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS is the device name listed in this FDA 510(k) record. The listed applicant is Mikron Makina Sanayi VE Ticaret Ltd. Sti.. It received FDA 510(k) clearance on 2013-12-16 under 510(k) number K130073. 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 MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS?

MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS is a medical device that received FDA 510(k) clearance on 2013-12-16. The listed applicant is Mikron Makina Sanayi VE Ticaret Ltd. Sti.. The 510(k) number is K130073.

When did MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS receive FDA 510(k) clearance?

MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS received FDA 510(k) clearance on 2013-12-16, under 510(k) number K130073.

Who is the listed applicant for MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS?

The FDA 510(k) record lists Mikron Makina Sanayi VE Ticaret Ltd. Sti. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS?

The FDA product code for MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS is MNI.

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 Mikron Makina Sanayi VE Ticaret Ltd. Sti. 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.

K241657MSFX MIKRON SPINAL FIXATION SYSTEMK240484MSFX Mikron Cervical Anterior Plate System

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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