FDA 510(k)

COUGAR® LS Lateral Cage System and COUGAR® System

K-Number: K162327 · 2016-12-12

Decision Date2016-12-12

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

COUGAR® LS Lateral Cage System and COUGAR® System is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2016-12-12 under 510(k) number K162327. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COUGAR® LS Lateral Cage System and COUGAR® System?

COUGAR® LS Lateral Cage System and COUGAR® System is a medical device that received FDA 510(k) clearance on 2016-12-12. The listed applicant is Medos International SARL. The 510(k) number is K162327.

When did COUGAR® LS Lateral Cage System and COUGAR® System receive FDA 510(k) clearance?

COUGAR® LS Lateral Cage System and COUGAR® System received FDA 510(k) clearance on 2016-12-12, under 510(k) number K162327.

Who is the listed applicant for COUGAR® LS Lateral Cage System and COUGAR® System?

The FDA 510(k) record lists Medos International SARL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COUGAR® LS Lateral Cage System and COUGAR® System?

The FDA product code for COUGAR® LS Lateral Cage System and COUGAR® System is MAX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04289480Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial AneurysmsACTIVE_NOT_RECRUITING NCT05316311A Study of Implantation of CRENEOUS ENTERPRISE 2 Intracranial Stent in Participants With Severe Symptomatic Intracranial Atherosclerotic StenosisCOMPLETED

Other records listing Medos International SARL as applicant

K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody K260240SYMPHONY Navigation Ready Instruments K253249TriALTIS™ Spine System K243249TriALTIS™ Spine System K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays K242042TriALTIS™ Spine System

View all 75 devices →

Related Devices (Code: MAX)

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.