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FDA 510(k)

MySpine Pedicle Screw Placement Guides - LP

K-Number: K153273 · 2016-06-29

ApplicantMedacta International S.A.
Decision Date2016-06-29
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MySpine Pedicle Screw Placement Guides - LP is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2016-06-29 under 510(k) number K153273. 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 MySpine Pedicle Screw Placement Guides - LP?

MySpine Pedicle Screw Placement Guides - LP is a medical device that received FDA 510(k) clearance on 2016-06-29. The listed applicant is Medacta International S.A.. The 510(k) number is K153273.

When did MySpine Pedicle Screw Placement Guides - LP receive FDA 510(k) clearance?

MySpine Pedicle Screw Placement Guides - LP received FDA 510(k) clearance on 2016-06-29, under 510(k) number K153273.

Who is the listed applicant for MySpine Pedicle Screw Placement Guides - LP?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MySpine Pedicle Screw Placement Guides - LP?

The FDA product code for MySpine Pedicle Screw Placement Guides - LP 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.

NCT07790068Evaluation of Safety of Complex Pedicle Screw Trajectories Using Patient-Specific Guides (MySpine, Medacta)ACTIVE_NOT_RECRUITINGNCT05565131Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine SurgeryCOMPLETEDNCT06960018Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw PlacementRECRUITING

Other records listing Medacta International S.A. 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.

K254202MectaLIF 3D Metal AnteriorK253940M.U.S.T. Pedicle Screw System - ExtensionK253328GMK 3D Metal Tibial Tray ExtensionK250644MSS - Monobloc stemK251043Mpact 3D Metal Implants Extension – DMLS TechnologyK252847NextAR Hip Platform

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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.K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.K160003Sniper (R) Spine SystemSpine Wave, Inc.

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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