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FDA 510(k)

PFC SIGMA Knee System

K-Number: K182301 · 2019-11-08

ApplicantDePuy Orthopaedics, Inc.
Decision Date2019-11-08
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PFC SIGMA Knee System is a medical device manufactured by DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2019-11-08 under approval number K182301. 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 PFC SIGMA Knee System?

PFC SIGMA Knee System is a medical device that received FDA 510(k) clearance on 2019-11-08. It is manufactured by DePuy Orthopaedics, Inc.. The 510(k) number is K182301.

When was PFC SIGMA Knee System approved by the FDA?

PFC SIGMA Knee System received FDA 510(k) clearance on 2019-11-08, under approval number K182301.

What company makes PFC SIGMA Knee System?

PFC SIGMA Knee System is manufactured by DePuy Orthopaedics, Inc..

What is the FDA product code for PFC SIGMA Knee System?

The FDA product code for PFC SIGMA Knee System is JWH.

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Other Devices by DePuy Orthopaedics, Inc.

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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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