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FDA 510(k)

MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides

K-Number: K220888 · 2022-05-24

ApplicantMedacta International S.A.
Decision Date2022-05-24
Product CodeQSR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides 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 2022-05-24 under 510(k) number K220888. The device is classified under product code QSR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides?

MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides is a medical device that received FDA 510(k) clearance on 2022-05-24. The listed applicant is Medacta International S.A.. The 510(k) number is K220888.

When did MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides receive FDA 510(k) clearance?

MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides received FDA 510(k) clearance on 2022-05-24, under 510(k) number K220888.

Who is the listed applicant for MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides?

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 S2-SI Pedicle and Sacro-Iliac Screw Placement Guides?

The FDA product code for MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides is QSR.

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 SurgeryCOMPLETEDNCT06636136Transtibial OsseointegrationRECRUITINGNCT06960018Clinical 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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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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