Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Mecta-C Stand Alone Extension

K-Number: K203076 · 2020-11-06

ApplicantMedacta International S.A.
Decision Date2020-11-06
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mecta-C Stand Alone Extension 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 2020-11-06 under 510(k) number K203076. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mecta-C Stand Alone Extension?

Mecta-C Stand Alone Extension is a medical device that received FDA 510(k) clearance on 2020-11-06. The listed applicant is Medacta International S.A.. The 510(k) number is K203076.

When did Mecta-C Stand Alone Extension receive FDA 510(k) clearance?

Mecta-C Stand Alone Extension received FDA 510(k) clearance on 2020-11-06, under 510(k) number K203076.

Who is the listed applicant for Mecta-C Stand Alone Extension?

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 Mecta-C Stand Alone Extension?

The FDA product code for Mecta-C Stand Alone Extension is OVE.

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

View all 146 devices →

Related Devices (Code: OVE)

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.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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.

↑