FDA 510(k)

ProMIS Fixation System

K-Number: K231844 · 2023-07-07

Decision Date2023-07-07

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ProMIS Fixation System is a medical device manufactured by Premia Spine, Ltd.. It received FDA 510(k) clearance on 2023-07-07 under approval number K231844. 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 Fixation System?

ProMIS Fixation System is a medical device that received FDA 510(k) clearance on 2023-07-07. It is manufactured by Premia Spine, Ltd.. The 510(k) number is K231844.

When was ProMIS Fixation System approved by the FDA?

ProMIS Fixation System received FDA 510(k) clearance on 2023-07-07, under approval number K231844.

What company makes ProMIS Fixation System?

ProMIS Fixation System is manufactured by Premia Spine, Ltd..

What is the FDA product code for ProMIS Fixation System?

The FDA product code for ProMIS Fixation System is NKB.

Related Clinical Trials

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Other Devices by Premia Spine, Ltd.

K170061ProMIS Fixation System K182598VersaLink Fixation System K191854Premia Spine XL Instruments K232719ProMIS Extension Rod System PMA P220002Prosthesis, posterior spinal elements

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

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.