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

FDA 510(k)

Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies

K-Number: K162903 · 2017-02-27

ApplicantExactech, Inc.
Decision Date2017-02-27
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2017-02-27 under approval number K162903. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies?

Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies is a medical device that received FDA 510(k) clearance on 2017-02-27. It is manufactured by Exactech, Inc.. The 510(k) number is K162903.

When was Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies approved by the FDA?

Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies received FDA 510(k) clearance on 2017-02-27, under approval number K162903.

What company makes Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies?

Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies is manufactured by Exactech, Inc..

What is the FDA product code for Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies?

The FDA product code for Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies is KWT.

Related Clinical Trials

NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT05707806 Development and Validation of Learning and Decision-Making Tasks RECRUITING NCT04947462 Proprioceptive Sensorimotor Integration With Neural Interfaces for Hand Prostheses RECRUITING NCT07595198 Platelet-Rich Fibrin (PRF) vs Bone Graft With Membrane for Ridge Preservation After Tooth Extraction NOT_YET_RECRUITING NCT07572253 A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation NOT_YET_RECRUITING NCT07589309 Comparative Effectiveness of Blood Flow Restriction With or Without Total Motion Release in ACL Rehabilitation COMPLETED

Other Devices by Exactech, Inc.

K153649Exactech® Novation® Element Press-fit Femoral Stem K160697Gibralt® Spine System and Gibralt® Occipital Spine System K153595Optetrak Logic Metaphyseal Cones K160484Optetrak Advanced Patella K152217Exactech Vantage Total Ankle System K153776Optetrak One Logic Femoral Components

View all 41 devices →

Related Devices (Code: KWT)

K161476SMR Shoulder SystemLima Corporate S.P.A. K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc. K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc. K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc. K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, 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.

↑