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FDA 510(k)

LOSPA Modular Knee System

K-Number: K160157 · 2016-12-01

ApplicantCorentec Co., Ltd.
Decision Date2016-12-01
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LOSPA Modular Knee System is a medical device manufactured by Corentec Co., Ltd.. It received FDA 510(k) clearance on 2016-12-01 under approval number K160157. 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 LOSPA Modular Knee System?

LOSPA Modular Knee System is a medical device that received FDA 510(k) clearance on 2016-12-01. It is manufactured by Corentec Co., Ltd.. The 510(k) number is K160157.

When was LOSPA Modular Knee System approved by the FDA?

LOSPA Modular Knee System received FDA 510(k) clearance on 2016-12-01, under approval number K160157.

What company makes LOSPA Modular Knee System?

LOSPA Modular Knee System is manufactured by Corentec Co., Ltd..

What is the FDA product code for LOSPA Modular Knee System?

The FDA product code for LOSPA Modular Knee System is JWH.

Related Clinical Trials

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Other Devices by Corentec Co., Ltd.

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup 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 K192507LOSPA II Knee System

View all 21 devices →

Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited 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. K162222GENflex2 Total Knee SystemStelkast, 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.

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