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FDA 510(k)

GMK NARROW

K-Number: K122232 · 2012-09-28

ApplicantMedacta International
Decision Date2012-09-28
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GMK NARROW is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International. It received FDA 510(k) clearance on 2012-09-28 under 510(k) number K122232. 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 GMK NARROW?

GMK NARROW is a medical device that received FDA 510(k) clearance on 2012-09-28. The listed applicant is Medacta International. The 510(k) number is K122232.

When did GMK NARROW receive FDA 510(k) clearance?

GMK NARROW received FDA 510(k) clearance on 2012-09-28, under 510(k) number K122232.

Who is the listed applicant for GMK NARROW?

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

What is the FDA product code for GMK NARROW?

The FDA product code for GMK NARROW 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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