FuzeFix Screw System
K-Number: K170038 · 2017-08-07
ApplicantFusion Orthopedics, LLC
Decision Date2017-08-07
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
FuzeFix Screw System is a medical device manufactured by Fusion Orthopedics, LLC. It received FDA 510(k) clearance on 2017-08-07 under approval number K170038. 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 FuzeFix Screw System?
FuzeFix Screw System is a medical device that received FDA 510(k) clearance on 2017-08-07. It is manufactured by Fusion Orthopedics, LLC. The 510(k) number is K170038.
When was FuzeFix Screw System approved by the FDA?
FuzeFix Screw System received FDA 510(k) clearance on 2017-08-07, under approval number K170038.
What company makes FuzeFix Screw System?
FuzeFix Screw System is manufactured by Fusion Orthopedics, LLC.
What is the FDA product code for FuzeFix Screw System?
The FDA product code for FuzeFix Screw 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.