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FDA 510(k)

Tarsa-Link Stand-Alone Wedge Fixation System

K-Number: K161037 · 2016-08-15

ApplicantLife Spine, Inc.
Decision Date2016-08-15
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tarsa-Link Stand-Alone Wedge Fixation System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2016-08-15 under approval number K161037. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tarsa-Link Stand-Alone Wedge Fixation System?

Tarsa-Link Stand-Alone Wedge Fixation System is a medical device that received FDA 510(k) clearance on 2016-08-15. It is manufactured by Life Spine, Inc.. The 510(k) number is K161037.

When was Tarsa-Link Stand-Alone Wedge Fixation System approved by the FDA?

Tarsa-Link Stand-Alone Wedge Fixation System received FDA 510(k) clearance on 2016-08-15, under approval number K161037.

What company makes Tarsa-Link Stand-Alone Wedge Fixation System?

Tarsa-Link Stand-Alone Wedge Fixation System is manufactured by Life Spine, Inc..

What is the FDA product code for Tarsa-Link Stand-Alone Wedge Fixation System?

The FDA product code for Tarsa-Link Stand-Alone Wedge Fixation System is HRS.

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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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