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)

ATTUNE Cemented Tibial Base, Fixed Bearing

K-Number: K170806 · 2017-06-15

ApplicantDepuy(Ireland)
Decision Date2017-06-15
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ATTUNE Cemented Tibial Base, Fixed Bearing is a medical device manufactured by Depuy(Ireland). It received FDA 510(k) clearance on 2017-06-15 under approval number K170806. 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 ATTUNE Cemented Tibial Base, Fixed Bearing?

ATTUNE Cemented Tibial Base, Fixed Bearing is a medical device that received FDA 510(k) clearance on 2017-06-15. It is manufactured by Depuy(Ireland). The 510(k) number is K170806.

When was ATTUNE Cemented Tibial Base, Fixed Bearing approved by the FDA?

ATTUNE Cemented Tibial Base, Fixed Bearing received FDA 510(k) clearance on 2017-06-15, under approval number K170806.

What company makes ATTUNE Cemented Tibial Base, Fixed Bearing?

ATTUNE Cemented Tibial Base, Fixed Bearing is manufactured by Depuy(Ireland).

What is the FDA product code for ATTUNE Cemented Tibial Base, Fixed Bearing?

The FDA product code for ATTUNE Cemented Tibial Base, Fixed Bearing is JWH.

Related Clinical Trials

NCT00435357 Comparison Between Fixed- Versus Mobile-bearing TKA COMPLETED NCT03153449 ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT07092579 Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Tibial Shaft Fractures RECRUITING

Other Devices by Depuy(Ireland)

K160907DePuy Actis DuoFix Hip Prosthesis K160700ATTUNE Revision Knee System K190344DePuy Corail AMT Hip Prosthesis K191779Attune Revision LPS Inserts K192448Delta Xtend Revers Shoulder System K183077Delta Xtend Reverse Shoulder System

View all 9 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.

↑