FDA 510(k)

Sphynx

K-Number: K160982 · 2016-12-22

Decision Date2016-12-22

Product CodeKWQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Sphynx is a medical device manufactured by Eden Spine, LLC. It received FDA 510(k) clearance on 2016-12-22 under approval number K160982. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sphynx?

Sphynx is a medical device that received FDA 510(k) clearance on 2016-12-22. It is manufactured by Eden Spine, LLC. The 510(k) number is K160982.

When was Sphynx approved by the FDA?

Sphynx received FDA 510(k) clearance on 2016-12-22, under approval number K160982.

What company makes Sphynx?

Sphynx is manufactured by Eden Spine, LLC.

What is the FDA product code for Sphynx?

The FDA product code for Sphynx is KWQ.

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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.