FDA 510(k)

VersaLink Fixation System

K-Number: K182598 · 2018-11-13

Decision Date2018-11-13

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

VersaLink Fixation System is a medical device manufactured by Premia Spine, Ltd.. It received FDA 510(k) clearance on 2018-11-13 under approval number K182598. 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 VersaLink Fixation System?

VersaLink Fixation System is a medical device that received FDA 510(k) clearance on 2018-11-13. It is manufactured by Premia Spine, Ltd.. The 510(k) number is K182598.

When was VersaLink Fixation System approved by the FDA?

VersaLink Fixation System received FDA 510(k) clearance on 2018-11-13, under approval number K182598.

What company makes VersaLink Fixation System?

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

What is the FDA product code for VersaLink Fixation System?

The FDA product code for VersaLink Fixation System is NKB.

Related Clinical Trials

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Other Devices by Premia Spine, Ltd.

K170061ProMIS Fixation System K191854Premia Spine XL Instruments K232719ProMIS Extension Rod System K231844ProMIS Fixation System PMA P220002Prosthesis, posterior spinal elements

Related Devices (Code: 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.