FDA 510(k)

VIRTU Lumbar Spacer System

K-Number: K160699 · 2016-08-01

Decision Date2016-08-01

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

VIRTU Lumbar Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Met 1 Technologies, LLC. It received FDA 510(k) clearance on 2016-08-01 under 510(k) number K160699. 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 VIRTU Lumbar Spacer System?

VIRTU Lumbar Spacer System is a medical device that received FDA 510(k) clearance on 2016-08-01. The listed applicant is Met 1 Technologies, LLC. The 510(k) number is K160699.

When did VIRTU Lumbar Spacer System receive FDA 510(k) clearance?

VIRTU Lumbar Spacer System received FDA 510(k) clearance on 2016-08-01, under 510(k) number K160699.

Who is the listed applicant for VIRTU Lumbar Spacer System?

The FDA 510(k) record lists Met 1 Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIRTU Lumbar Spacer System?

The FDA product code for VIRTU Lumbar Spacer System is MAX.

Other records listing Met 1 Technologies, LLC as applicant

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.

K161649Virtu C Spinal Implant System

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Official Source

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