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FDA 510(k)

MySpine Unilateral Guides

K-Number: K231483 · 2023-07-21

ApplicantMedacta International S.A.
Decision Date2023-07-21
Product CodePQC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MySpine Unilateral 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 2023-07-21 under 510(k) number K231483. 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 Unilateral Guides?

MySpine Unilateral Guides is a medical device that received FDA 510(k) clearance on 2023-07-21. The listed applicant is Medacta International S.A.. The 510(k) number is K231483.

When did MySpine Unilateral Guides receive FDA 510(k) clearance?

MySpine Unilateral Guides received FDA 510(k) clearance on 2023-07-21, under 510(k) number K231483.

Who is the listed applicant for MySpine Unilateral 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 Unilateral Guides?

The FDA product code for MySpine Unilateral Guides is PQC.

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: 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 MedicalK203673MySpine 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.K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SAK181883FIREFLY® 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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