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FDA 510(k)

HLS KNEETEC SYSTEM

K-Number: K094013 · 2011-05-05

ApplicantTornier
Decision Date2011-05-05
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HLS KNEETEC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tornier. It received FDA 510(k) clearance on 2011-05-05 under 510(k) number K094013. 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 HLS KNEETEC SYSTEM?

HLS KNEETEC SYSTEM is a medical device that received FDA 510(k) clearance on 2011-05-05. The listed applicant is Tornier. The 510(k) number is K094013.

When did HLS KNEETEC SYSTEM receive FDA 510(k) clearance?

HLS KNEETEC SYSTEM received FDA 510(k) clearance on 2011-05-05, under 510(k) number K094013.

Who is the listed applicant for HLS KNEETEC SYSTEM?

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

What is the FDA product code for HLS KNEETEC SYSTEM?

The FDA product code for HLS KNEETEC SYSTEM is JWH.

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Related Devices (Code: 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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