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)

Medacta Anatomic Shoulder Prosthesis

K-Number: K170910 · 2017-08-16

ApplicantMedacta International S.A.
Decision Date2017-08-16
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medacta Anatomic Shoulder Prosthesis 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 2017-08-16 under 510(k) number K170910. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medacta Anatomic Shoulder Prosthesis?

Medacta Anatomic Shoulder Prosthesis is a medical device that received FDA 510(k) clearance on 2017-08-16. The listed applicant is Medacta International S.A.. The 510(k) number is K170910.

When did Medacta Anatomic Shoulder Prosthesis receive FDA 510(k) clearance?

Medacta Anatomic Shoulder Prosthesis received FDA 510(k) clearance on 2017-08-16, under 510(k) number K170910.

Who is the listed applicant for Medacta Anatomic Shoulder Prosthesis?

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 Medacta Anatomic Shoulder Prosthesis?

The FDA product code for Medacta Anatomic Shoulder Prosthesis is KWS.

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.

NCT05002959TESS V3 Modular Total Shoulder System PMCFTERMINATED

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: KWS)

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.

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, Inc.)

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.

↑