FDA 510(k)

COUGAR SYSTEM

K-Number: K113348 · 2011-12-13

Decision Date2011-12-13

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

COUGAR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson. It received FDA 510(k) clearance on 2011-12-13 under 510(k) number K113348. 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 SYSTEM?

COUGAR SYSTEM is a medical device that received FDA 510(k) clearance on 2011-12-13. The listed applicant is Johnson & Johnson. The 510(k) number is K113348.

When did COUGAR SYSTEM receive FDA 510(k) clearance?

COUGAR SYSTEM received FDA 510(k) clearance on 2011-12-13, under 510(k) number K113348.

Who is the listed applicant for COUGAR SYSTEM?

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

What is the FDA product code for COUGAR SYSTEM?

The FDA product code for COUGAR SYSTEM is MAX.

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Other records listing Johnson & Johnson as applicant

K113273SPOTLIGHT ACCESS SYSTEM K112913SPOTLIGHT ACCESS SYSTEM K110551EXPEDIUM SPINE SYSTEM K110694CONCORDE BULLET SPINAL SYSTEM K111571VIPER SYSTEMS K110454COUGAR LS LATERAL CAGE SYSTEM

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Related Devices (Code: MAX)

K261049SCALA® TLSpineart SA 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.

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.