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)

EXULT Femoral component trial - Left, EXULT Femoral component trial - Right

K-Number: K201851 · 2020-07-30

ApplicantCorentec Co., Ltd.
Decision Date2020-07-30
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXULT Femoral component trial - Left, EXULT Femoral component trial - Right is a medical device manufactured by Corentec Co., Ltd.. It received FDA 510(k) clearance on 2020-07-30 under approval number K201851. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXULT Femoral component trial - Left, EXULT Femoral component trial - Right?

EXULT Femoral component trial - Left, EXULT Femoral component trial - Right is a medical device that received FDA 510(k) clearance on 2020-07-30. It is manufactured by Corentec Co., Ltd.. The 510(k) number is K201851.

When was EXULT Femoral component trial - Left, EXULT Femoral component trial - Right approved by the FDA?

EXULT Femoral component trial - Left, EXULT Femoral component trial - Right received FDA 510(k) clearance on 2020-07-30, under approval number K201851.

What company makes EXULT Femoral component trial - Left, EXULT Femoral component trial - Right?

EXULT Femoral component trial - Left, EXULT Femoral component trial - Right is manufactured by Corentec Co., Ltd..

What is the FDA product code for EXULT Femoral component trial - Left, EXULT Femoral component trial - Right?

The FDA product code for EXULT Femoral component trial - Left, EXULT Femoral component trial - Right is JWH.

Related Clinical Trials

NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT07599774 Optimal Targeted High-definition Transcranial Direct Current Stimulation for Reducing Post-stroke Upper Limb Motor Impairments NOT_YET_RECRUITING NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT05147363 Shockwave: Disruption for A Better Fit WITHDRAWN NCT06968026 Right Prefrontal Autonomic Mapping in Recurrent Pregnancy Loss With Comorbid Anxiety RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING

Other Devices by Corentec Co., Ltd.

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup System K160157LOSPA Modular Knee System K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug K172806Bencox Mirabo Cup System K170243LOSPA IS TLIF & DLIF Cages K161641LOSPA IS ACP System

View all 21 devices →

Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

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.

↑