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FDA 510(k)

BKS Revision Sleeves System

K-Number: K181569 · 2018-10-12

ApplicantOrtho Development Corporation
Decision Date2018-10-12
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BKS Revision Sleeves System is a medical device manufactured by Ortho Development Corporation. It received FDA 510(k) clearance on 2018-10-12 under approval number K181569. 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 BKS Revision Sleeves System?

BKS Revision Sleeves System is a medical device that received FDA 510(k) clearance on 2018-10-12. It is manufactured by Ortho Development Corporation. The 510(k) number is K181569.

When was BKS Revision Sleeves System approved by the FDA?

BKS Revision Sleeves System received FDA 510(k) clearance on 2018-10-12, under approval number K181569.

What company makes BKS Revision Sleeves System?

BKS Revision Sleeves System is manufactured by Ortho Development Corporation.

What is the FDA product code for BKS Revision Sleeves System?

The FDA product code for BKS Revision Sleeves System is JWH.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING

Other Devices by Ortho Development Corporation

K161080Escalade Legend Acetabular Shell K153216Alpine Cemented Hip System K171249Entrada™ hip stem K162995Ibis® Pedicle Screw System K182085Balanced Knee Revision System Trabecular Tibial Cone Augments K180743Balanced Knee Revision System - Offset Junction Box

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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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