FDA 510(k)

JOURNEY II DEEP DISHED ARTICULAR INSERTS

K-Number: K113482 · 2012-02-27

Decision Date2012-02-27

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

JOURNEY II DEEP DISHED ARTICULAR INSERTS 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 2012-02-27 under 510(k) number K113482. 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 JOURNEY II DEEP DISHED ARTICULAR INSERTS?

JOURNEY II DEEP DISHED ARTICULAR INSERTS is a medical device that received FDA 510(k) clearance on 2012-02-27. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K113482.

When did JOURNEY II DEEP DISHED ARTICULAR INSERTS receive FDA 510(k) clearance?

JOURNEY II DEEP DISHED ARTICULAR INSERTS received FDA 510(k) clearance on 2012-02-27, under 510(k) number K113482.

Who is the listed applicant for JOURNEY II DEEP DISHED ARTICULAR INSERTS?

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 JOURNEY II DEEP DISHED ARTICULAR INSERTS?

The FDA product code for JOURNEY II DEEP DISHED ARTICULAR INSERTS 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.