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FDA 510(k)

MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides

K-Number: K200792 · 2020-10-05

ApplicantMedacta Inernational SA
Decision Date2020-10-05
Product CodePQC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides is the device name listed in this FDA 510(k) record. The listed applicant is Medacta Inernational SA. It received FDA 510(k) clearance on 2020-10-05 under 510(k) number K200792. The device is classified under product code PQC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides?

MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides is a medical device that received FDA 510(k) clearance on 2020-10-05. The listed applicant is Medacta Inernational SA. The 510(k) number is K200792.

When did MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides receive FDA 510(k) clearance?

MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides received FDA 510(k) clearance on 2020-10-05, under 510(k) number K200792.

Who is the listed applicant for MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides?

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

What is the FDA product code for MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides?

The FDA product code for MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides is PQC.

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 Inernational SA 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.

K200551MectaLIF Transforaminal TiPEEKK193175Lateralized GlenosphereK193559NextAR TKA Platform

Related Devices (Code: PQC)

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.

K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak MedicalK231483MySpine Unilateral GuidesMedacta International S.A.K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)Medacta International S.A.K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.

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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