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FDA 510(k)

Attune Revision Sleeve LPS Femoral Adaptors

K-Number: K202248 · 2020-12-28

ApplicantDepuy Ireland UC
Decision Date2020-12-28
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Attune Revision Sleeve LPS Femoral Adaptors is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2020-12-28 under approval number K202248. 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 Revision Sleeve LPS Femoral Adaptors?

Attune Revision Sleeve LPS Femoral Adaptors is a medical device that received FDA 510(k) clearance on 2020-12-28. It is manufactured by Depuy Ireland UC. The 510(k) number is K202248.

When was Attune Revision Sleeve LPS Femoral Adaptors approved by the FDA?

Attune Revision Sleeve LPS Femoral Adaptors received FDA 510(k) clearance on 2020-12-28, under approval number K202248.

What company makes Attune Revision Sleeve LPS Femoral Adaptors?

Attune Revision Sleeve LPS Femoral Adaptors is manufactured by Depuy Ireland UC.

What is the FDA product code for Attune Revision Sleeve LPS Femoral Adaptors?

The FDA product code for Attune Revision Sleeve LPS Femoral Adaptors is JWH.

Related Clinical Trials

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 NCT07571408 Intraoperative Application of Cold Atmospheric Plasma to Prevent Postoperative Wound Complications in the Inguinal Region of High-risk Patients With Peripheral Arterial Occlusive Disease NOT_YET_RECRUITING NCT04090359 Dual Mobility Acetabular Cups in Revision TJA RECRUITING

Other Devices by Depuy Ireland UC

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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.

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