FDA 510(k)

HammerTechTM Fixation System

K-Number: K182684 · 2018-11-23

Decision Date2018-11-23

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

HammerTechTM 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 2018-11-23 under 510(k) number K182684. 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 HammerTechTM Fixation System?

HammerTechTM Fixation System is a medical device that received FDA 510(k) clearance on 2018-11-23. The listed applicant is Fusion Orthopedics, LLC. The 510(k) number is K182684.

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

HammerTechTM Fixation System received FDA 510(k) clearance on 2018-11-23, under 510(k) number K182684.

Who is the listed applicant for HammerTechTM 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 HammerTechTM Fixation System?

The FDA product code for HammerTechTM 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.