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FDA 510(k)

GMK - LINE EXTENSION

K-Number: K120790 · 2012-06-08

ApplicantMedacta International
Decision Date2012-06-08
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GMK - LINE EXTENSION is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International. It received FDA 510(k) clearance on 2012-06-08 under 510(k) number K120790. 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 - LINE EXTENSION?

GMK - LINE EXTENSION is a medical device that received FDA 510(k) clearance on 2012-06-08. The listed applicant is Medacta International. The 510(k) number is K120790.

When did GMK - LINE EXTENSION receive FDA 510(k) clearance?

GMK - LINE EXTENSION received FDA 510(k) clearance on 2012-06-08, under 510(k) number K120790.

Who is the listed applicant for GMK - LINE EXTENSION?

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 - LINE EXTENSION?

The FDA product code for GMK - LINE EXTENSION 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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