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FDA 510(k)

Juliet Ti

K-Number: K181203 · 2018-06-28

ApplicantSpineart
Decision Date2018-06-28
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Juliet Ti is a medical device manufactured by Spineart. It received FDA 510(k) clearance on 2018-06-28 under approval number K181203. 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 2018-06-28. It is manufactured by Spineart. The 510(k) number is K181203.

When was Juliet Ti approved by the FDA?

Juliet Ti received FDA 510(k) clearance on 2018-06-28, under approval number K181203.

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

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