FDA 510(k)

Tiger Cannulated Screw System

K-Number: K153338 · 2016-01-14

Decision Date2016-01-14

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Tiger Cannulated Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Trilliant Surgical, Ltd.. It received FDA 510(k) clearance on 2016-01-14 under 510(k) 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. The listed applicant is Trilliant Surgical, Ltd.. The 510(k) number is K153338.

When did Tiger Cannulated Screw System receive FDA 510(k) clearance?

Tiger Cannulated Screw System received FDA 510(k) clearance on 2016-01-14, under 510(k) number K153338.

Who is the listed applicant for Tiger Cannulated Screw System?

The FDA 510(k) record lists Trilliant Surgical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Trilliant Surgical, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212378Arsenal Ankle Plating System K191009Arsenal Plating System K181898Two-Step Implant System K172405SNIPER STAPLE SYSTEM, NON-STERILE K172178Minimally Invasive Bunion Plating System K162354Sniper Staple System

View all 8 devices →

Related Devices (Code: HWC)

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLC K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps Ortho K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

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.