FDA 510(k)

Relign System

K-Number: K162770 · 2017-01-04

Decision Date2017-01-04

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Relign System is a medical device manufactured by Relign Corporation. It received FDA 510(k) clearance on 2017-01-04 under approval number K162770. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Relign System?

Relign System is a medical device that received FDA 510(k) clearance on 2017-01-04. It is manufactured by Relign Corporation. The 510(k) number is K162770.

When was Relign System approved by the FDA?

Relign System received FDA 510(k) clearance on 2017-01-04, under approval number K162770.

What company makes Relign System?

Relign System is manufactured by Relign Corporation.

What is the FDA product code for Relign System?

The FDA product code for Relign System is GEI.

Other Devices by Relign Corporation

K233493Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024)

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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.