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FDA 510(k)

TISSUE FIXATION SYSTEM

K-Number: K050418 · 2005-05-16

ApplicantTfs Manufacturing Pty, Ltd.
Decision Date2005-05-16
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TISSUE FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tfs Manufacturing Pty, Ltd.. It received FDA 510(k) clearance on 2005-05-16 under 510(k) number K050418. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TISSUE FIXATION SYSTEM?

TISSUE FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2005-05-16. The listed applicant is Tfs Manufacturing Pty, Ltd.. The 510(k) number is K050418.

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

TISSUE FIXATION SYSTEM received FDA 510(k) clearance on 2005-05-16, under 510(k) number K050418.

Who is the listed applicant for TISSUE FIXATION SYSTEM?

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

What is the FDA product code for TISSUE FIXATION SYSTEM?

The FDA product code for TISSUE FIXATION SYSTEM is FTL.

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Related Devices (Code: FTL)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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