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FDA 510(k)

GMK SHORT STEM

K-Number: K133630 · 2013-12-20

ApplicantMedacta International
Decision Date2013-12-20
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GMK SHORT STEM is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K133630. 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 SHORT STEM?

GMK SHORT STEM is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Medacta International. The 510(k) number is K133630.

When did GMK SHORT STEM receive FDA 510(k) clearance?

GMK SHORT STEM received FDA 510(k) clearance on 2013-12-20, under 510(k) number K133630.

Who is the listed applicant for GMK SHORT STEM?

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 SHORT STEM?

The FDA product code for GMK SHORT STEM is JWH.

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Other records listing Medacta International as applicant

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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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