HammerTech Fixation System
K-Number: K161449 · 2016-10-11
ApplicantFusion Orthopedics, LLC
Decision Date2016-10-11
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
HammerTech Fixation System is a medical device manufactured by Fusion Orthopedics, LLC. It received FDA 510(k) clearance on 2016-10-11 under approval 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. It is manufactured by Fusion Orthopedics, LLC. The 510(k) number is K161449.
When was HammerTech Fixation System approved by the FDA?
HammerTech Fixation System received FDA 510(k) clearance on 2016-10-11, under approval number K161449.
What company makes HammerTech Fixation System?
HammerTech Fixation System is manufactured by Fusion Orthopedics, LLC.
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.
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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.