Tiger Cannulated Screw System
K-Number: K153338 · 2016-01-14
ApplicantTrilliant Surgical, Ltd.
Decision Date2016-01-14
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Tiger Cannulated Screw System is a medical device manufactured by Trilliant Surgical, Ltd.. It received FDA 510(k) clearance on 2016-01-14 under approval number K153338. 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 Tiger Cannulated Screw System?
Tiger Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2016-01-14. It is manufactured by Trilliant Surgical, Ltd.. The 510(k) number is K153338.
When was Tiger Cannulated Screw System approved by the FDA?
Tiger Cannulated Screw System received FDA 510(k) clearance on 2016-01-14, under approval number K153338.
What company makes Tiger Cannulated Screw System?
Tiger Cannulated Screw System is manufactured by Trilliant Surgical, Ltd..
What is the FDA product code for Tiger Cannulated Screw System?
The FDA product code for Tiger Cannulated 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.