FDA 510(k)

NAJA Ligament Correction System

K-Number: K172206 · 2018-04-10

Decision Date2018-04-10

Product CodeOWI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

NAJA Ligament Correction System is a medical device manufactured by Cousin Biotech Sas. It received FDA 510(k) clearance on 2018-04-10 under approval number K172206. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAJA Ligament Correction System?

NAJA Ligament Correction System is a medical device that received FDA 510(k) clearance on 2018-04-10. It is manufactured by Cousin Biotech Sas. The 510(k) number is K172206.

When was NAJA Ligament Correction System approved by the FDA?

NAJA Ligament Correction System received FDA 510(k) clearance on 2018-04-10, under approval number K172206.

What company makes NAJA Ligament Correction System?

NAJA Ligament Correction System is manufactured by Cousin Biotech Sas.

What is the FDA product code for NAJA Ligament Correction System?

The FDA product code for NAJA Ligament Correction System is OWI.

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Other Devices by Cousin Biotech Sas

K181799ResCUBE Ligament Fixation System K181086Cortical Fixation Systems

Related Devices (Code: OWI)

K160698LigaPASSMedicrea International SA K161267Response BandLoc Spinal FixationOrthoPediatrics Corp. K161265NuVasive® VersaTie SystemNu Vasive, Incorporated K153348JAZZ LOCKImplanet, S.A. K160208NILE Alternative Fixation Spinal SystemK2m, Inc. K173117NuVasive® VersaTie SystemNuvasive, 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.