FDA 510(k)

ProMIS Extension Rod System

K-Number: K232719 · 2023-11-21

Decision Date2023-11-21

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ProMIS Extension Rod System is a medical device manufactured by Premia Spine, Ltd.. It received FDA 510(k) clearance on 2023-11-21 under approval number K232719. 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 ProMIS Extension Rod System?

ProMIS Extension Rod System is a medical device that received FDA 510(k) clearance on 2023-11-21. It is manufactured by Premia Spine, Ltd.. The 510(k) number is K232719.

When was ProMIS Extension Rod System approved by the FDA?

ProMIS Extension Rod System received FDA 510(k) clearance on 2023-11-21, under approval number K232719.

What company makes ProMIS Extension Rod System?

ProMIS Extension Rod System is manufactured by Premia Spine, Ltd..

What is the FDA product code for ProMIS Extension Rod System?

The FDA product code for ProMIS Extension Rod System is NKB.

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Other Devices by Premia Spine, Ltd.

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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.