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FDA 510(k)

JAX

K-Number: K010555 · 2003-02-25

ApplicantSmith & Nephew, Inc.
Decision Date2003-02-25
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JAX is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2003-02-25 under 510(k) number K010555. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JAX?

JAX is a medical device that received FDA 510(k) clearance on 2003-02-25. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K010555.

When did JAX receive FDA 510(k) clearance?

JAX received FDA 510(k) clearance on 2003-02-25, under 510(k) number K010555.

Who is the listed applicant for JAX?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JAX?

The FDA product code for JAX is MQV.

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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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