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FDA 510(k)

K2M Fenestrated Tap System

K-Number: K152872 · 2016-01-05

ApplicantK2m
Decision Date2016-01-05
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

K2M Fenestrated Tap System is the device name listed in this FDA 510(k) record. The listed applicant is K2m. It received FDA 510(k) clearance on 2016-01-05 under 510(k) number K152872. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K2M Fenestrated Tap System?

K2M Fenestrated Tap System is a medical device that received FDA 510(k) clearance on 2016-01-05. The listed applicant is K2m. The 510(k) number is K152872.

When did K2M Fenestrated Tap System receive FDA 510(k) clearance?

K2M Fenestrated Tap System received FDA 510(k) clearance on 2016-01-05, under 510(k) number K152872.

Who is the listed applicant for K2M Fenestrated Tap System?

The FDA 510(k) record lists K2m as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K2M Fenestrated Tap System?

The FDA product code for K2M Fenestrated Tap System is KNW.

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Related Devices (Code: KNW)

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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