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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 a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2016-06-29 under approval 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. It is manufactured by Medacta International S.A.. The 510(k) number is K153273.

When was MySpine Pedicle Screw Placement Guides - LP approved by the FDA?

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

What company makes MySpine Pedicle Screw Placement Guides - LP?

MySpine Pedicle Screw Placement Guides - LP is manufactured by Medacta International S.A..

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

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07551024 Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic Maxilla RECRUITING NCT07515092 Virtual Reality-Based Simulation Training for Antegrade Anterior Column Acetabular Screw Placement in Orthopedic Residents ENROLLING_BY_INVITATION NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT06960018 Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement RECRUITING

Related PubMed Literature

PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025)

Other Devices by Medacta International S.A.

K163311GMK Revision Femoral Distal Augmentation K162061M.U.S.T. Pedicle Screw System K171058Medacta Shoulder System: Threaded Glenoid Baseplate K173267MasterLoc Stem: Lateralized Plus K170690M-Vizion Femoral Revision System K172347GMK Hinge, GMK Revision

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Related Devices (Code: MNI)

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. K152324YAHUA Spinal SystemBeijing Weigao Yahua Artificial Joint Development 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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