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FDA 510(k)

SPAR-K Instruments (for use with Gemini SL Total Knee System)

K-Number: K191755 · 2019-07-18

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2019-07-18
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPAR-K Instruments (for use with Gemini SL Total Knee System) 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 2019-07-18 under 510(k) number K191755. 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 SPAR-K Instruments (for use with Gemini SL Total Knee System)?

SPAR-K Instruments (for use with Gemini SL Total Knee System) is a medical device that received FDA 510(k) clearance on 2019-07-18. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K191755.

When did SPAR-K Instruments (for use with Gemini SL Total Knee System) receive FDA 510(k) clearance?

SPAR-K Instruments (for use with Gemini SL Total Knee System) received FDA 510(k) clearance on 2019-07-18, under 510(k) number K191755.

Who is the listed applicant for SPAR-K Instruments (for use with Gemini SL Total Knee System)?

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 SPAR-K Instruments (for use with Gemini SL Total Knee System)?

The FDA product code for SPAR-K Instruments (for use with Gemini SL Total Knee System) is JWH.

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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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