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FDA 510(k)

CONCORDE BULLET CAGE SYSTEM

K-Number: K103488 · 2011-03-02

ApplicantJohnson and Johnson
Decision Date2011-03-02
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONCORDE BULLET CAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Johnson and Johnson. It received FDA 510(k) clearance on 2011-03-02 under 510(k) number K103488. 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 CONCORDE BULLET CAGE SYSTEM?

CONCORDE BULLET CAGE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-03-02. The listed applicant is Johnson and Johnson. The 510(k) number is K103488.

When did CONCORDE BULLET CAGE SYSTEM receive FDA 510(k) clearance?

CONCORDE BULLET CAGE SYSTEM received FDA 510(k) clearance on 2011-03-02, under 510(k) number K103488.

Who is the listed applicant for CONCORDE BULLET CAGE SYSTEM?

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

What is the FDA product code for CONCORDE BULLET CAGE SYSTEM?

The FDA product code for CONCORDE BULLET CAGE SYSTEM is MAX.

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Other records listing Johnson and Johnson as applicant

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.

K113273SPOTLIGHT ACCESS SYSTEMK112913SPOTLIGHT ACCESS SYSTEMK113348COUGAR SYSTEMK110551EXPEDIUM SPINE SYSTEMK110694CONCORDE BULLET SPINAL SYSTEMK111571VIPER SYSTEMS

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Related Devices (Code: MAX)

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.

K261049SCALA® TLSpineart SAK261430TruLift 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 CorporationK253151Fule 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.

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