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FDA 510(k)

The Plateau-LO Spacer System

K-Number: K172105 · 2018-02-02

Decision Date2018-02-02
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The Plateau-LO Spacer System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2018-02-02 under approval number K172105. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Plateau-LO Spacer System?

The Plateau-LO Spacer System is a medical device that received FDA 510(k) clearance on 2018-02-02. It is manufactured by Life Spine, Inc.. The 510(k) number is K172105.

When was The Plateau-LO Spacer System approved by the FDA?

The Plateau-LO Spacer System received FDA 510(k) clearance on 2018-02-02, under approval number K172105.

What company makes The Plateau-LO Spacer System?

The Plateau-LO Spacer System is manufactured by Life Spine, Inc..

What is the FDA product code for The Plateau-LO Spacer System?

The FDA product code for The Plateau-LO Spacer System is MAX.

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Official Source

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