FDA 510(k)

Juliet® Ti

K-Number: K153621 · 2016-07-15

Decision Date2016-07-15

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Juliet® Ti is a medical device manufactured by Spineart. It received FDA 510(k) clearance on 2016-07-15 under approval number K153621. 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 Juliet® Ti?

Juliet® Ti is a medical device that received FDA 510(k) clearance on 2016-07-15. It is manufactured by Spineart. The 510(k) number is K153621.

When was Juliet® Ti approved by the FDA?

Juliet® Ti received FDA 510(k) clearance on 2016-07-15, under approval number K153621.

What company makes Juliet® Ti?

Juliet® Ti is manufactured by Spineart.

What is the FDA product code for Juliet® Ti?

The FDA product code for Juliet® Ti is MAX.

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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.