FDA 510(k)

COPAL knee moulds

K-Number: K222570 · 2023-02-04

Decision Date2023-02-04

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

COPAL knee moulds is a medical device manufactured by Heraeus Medical GmbH. It received FDA 510(k) clearance on 2023-02-04 under approval number K222570. 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 COPAL knee moulds?

COPAL knee moulds is a medical device that received FDA 510(k) clearance on 2023-02-04. It is manufactured by Heraeus Medical GmbH. The 510(k) number is K222570.

When was COPAL knee moulds approved by the FDA?

COPAL knee moulds received FDA 510(k) clearance on 2023-02-04, under approval number K222570.

What company makes COPAL knee moulds?

COPAL knee moulds is manufactured by Heraeus Medical GmbH.

What is the FDA product code for COPAL knee moulds?

The FDA product code for COPAL knee moulds is JWH.

Other Devices by Heraeus Medical GmbH

K153737OSTEOPAL plus K182260PALACOS MV K191016COPAL exchange G Hip and Knee Spacers K190766PALACOS fast R+G K202475PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro

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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.