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FDA 510(k)

TLS FIXATION SYSTEM

K-Number: K080974 · 2008-07-01

ApplicantFournitures Hospitalieres Industrie
Decision Date2008-07-01
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TLS FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fournitures Hospitalieres Industrie. It received FDA 510(k) clearance on 2008-07-01 under 510(k) number K080974. 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 TLS FIXATION SYSTEM?

TLS FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-01. The listed applicant is Fournitures Hospitalieres Industrie. The 510(k) number is K080974.

When did TLS FIXATION SYSTEM receive FDA 510(k) clearance?

TLS FIXATION SYSTEM received FDA 510(k) clearance on 2008-07-01, under 510(k) number K080974.

Who is the listed applicant for TLS FIXATION SYSTEM?

The FDA 510(k) record lists Fournitures Hospitalieres Industrie as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TLS FIXATION SYSTEM?

The FDA product code for TLS 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.

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