FDA 510(k)

Invictus OsseoScrew® System

K-Number: K202327 · 2020-10-15

Decision Date2020-10-15

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Invictus OsseoScrew® System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2020-10-15 under approval number K202327. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Invictus OsseoScrew® System?

Invictus OsseoScrew® System is a medical device that received FDA 510(k) clearance on 2020-10-15. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K202327.

When was Invictus OsseoScrew® System approved by the FDA?

Invictus OsseoScrew® System received FDA 510(k) clearance on 2020-10-15, under approval number K202327.

What company makes Invictus OsseoScrew® System?

Invictus OsseoScrew® System is manufactured by Alphatec Spine, Inc..

What is the FDA product code for Invictus OsseoScrew® System?

The FDA product code for Invictus OsseoScrew® System is NKB.

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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.