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FDA 510(k)

TIGER CANNULATED SCREW SYSTEM

K-Number: K081510 · 2008-08-04

ApplicantTrilliant Surgical, Ltd.
Decision Date2008-08-04
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 2008-08-04 under 510(k) number K081510. 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 2008-08-04. The listed applicant is Trilliant Surgical, Ltd.. The 510(k) number is K081510.

When did TIGER CANNULATED SCREW SYSTEM receive FDA 510(k) clearance?

TIGER CANNULATED SCREW SYSTEM received FDA 510(k) clearance on 2008-08-04, under 510(k) number K081510.

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.

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Related Devices (Code: HWC)

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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.

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