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FDA 510(k)

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface

K-Number: K230471 · 2023-03-21

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2023-03-21
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface is the device name listed in this FDA 510(k) record. The listed applicant is Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2023-03-21 under 510(k) number K230471. 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 LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface?

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface is a medical device that received FDA 510(k) clearance on 2023-03-21. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K230471.

When did LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface receive FDA 510(k) clearance?

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface received FDA 510(k) clearance on 2023-03-21, under 510(k) number K230471.

Who is the listed applicant for LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface?

The FDA 510(k) record lists Waldemar Link GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface?

The FDA product code for LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface is JWH.

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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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