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FDA 510(k)

LOSPA II Knee System (EXULT Knee Replacement System)

K-Number: K200395 · 2020-05-07

ApplicantCorentec Co., Ltd.
Decision Date2020-05-07
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LOSPA II Knee System (EXULT Knee Replacement System) is the device name listed in this FDA 510(k) record. The listed applicant is Corentec Co., Ltd.. It received FDA 510(k) clearance on 2020-05-07 under 510(k) number K200395. 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 II Knee System (EXULT Knee Replacement System)?

LOSPA II Knee System (EXULT Knee Replacement System) is a medical device that received FDA 510(k) clearance on 2020-05-07. The listed applicant is Corentec Co., Ltd.. The 510(k) number is K200395.

When did LOSPA II Knee System (EXULT Knee Replacement System) receive FDA 510(k) clearance?

LOSPA II Knee System (EXULT Knee Replacement System) received FDA 510(k) clearance on 2020-05-07, under 510(k) number K200395.

Who is the listed applicant for LOSPA II Knee System (EXULT Knee Replacement System)?

The FDA 510(k) record lists Corentec Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOSPA II Knee System (EXULT Knee Replacement System)?

The FDA product code for LOSPA II Knee System (EXULT Knee Replacement System) is JWH.

Other records listing Corentec Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250889EXULT Knee Replacement SystemK242401EXULT Knee Replacement SystemK242046EXULT Knee Replacement SystemK223828BENCOX Delta Option HeadsK223223BENCOX Mirabo Z Cup CortiniumK222278LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation

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Related Devices (Code: JWH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

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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