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FDA 510(k)

EXULT Femoral component trial - Left, EXULT Femoral component trial - Right

K-Number: K201851 · 2020-07-30

ApplicantCorentec Co., Ltd.
Decision Date2020-07-30
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXULT Femoral component trial - Left, EXULT Femoral component trial - Right 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 2020-07-30 under 510(k) number K201851. 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 EXULT Femoral component trial - Left, EXULT Femoral component trial - Right?

EXULT Femoral component trial - Left, EXULT Femoral component trial - Right is a medical device that received FDA 510(k) clearance on 2020-07-30. The listed applicant is Corentec Co., Ltd.. The 510(k) number is K201851.

When did EXULT Femoral component trial - Left, EXULT Femoral component trial - Right receive FDA 510(k) clearance?

EXULT Femoral component trial - Left, EXULT Femoral component trial - Right received FDA 510(k) clearance on 2020-07-30, under 510(k) number K201851.

Who is the listed applicant for EXULT Femoral component trial - Left, EXULT Femoral component trial - Right?

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 EXULT Femoral component trial - Left, EXULT Femoral component trial - Right?

The FDA product code for EXULT Femoral component trial - Left, EXULT Femoral component trial - Right is JWH.

Other records listing Corentec Co., Ltd. as applicant

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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.

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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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