FDA 510(k)

HammerTech Fixation System

K-Number: K161449 · 2016-10-11

Decision Date2016-10-11

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

HammerTech Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Fusion Orthopedics, LLC. It received FDA 510(k) clearance on 2016-10-11 under 510(k) number K161449. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HammerTech Fixation System?

HammerTech Fixation System is a medical device that received FDA 510(k) clearance on 2016-10-11. The listed applicant is Fusion Orthopedics, LLC. The 510(k) number is K161449.

When did HammerTech Fixation System receive FDA 510(k) clearance?

HammerTech Fixation System received FDA 510(k) clearance on 2016-10-11, under 510(k) number K161449.

Who is the listed applicant for HammerTech Fixation System?

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

What is the FDA product code for HammerTech Fixation System?

The FDA product code for HammerTech Fixation System is HWC. This falls under the Cardiovascular category.

Other records listing Fusion Orthopedics, LLC as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.