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FDA 510(k)

CONCORDE CURVE SYSTEM

K-Number: K103743 · 2011-03-17

ApplicantJohnson & Johnson
Decision Date2011-03-17
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONCORDE CURVE 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 2011-03-17 under 510(k) number K103743. 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 CURVE SYSTEM?

CONCORDE CURVE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-03-17. The listed applicant is Johnson & Johnson. The 510(k) number is K103743.

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

CONCORDE CURVE SYSTEM received FDA 510(k) clearance on 2011-03-17, under 510(k) number K103743.

Who is the listed applicant for CONCORDE CURVE 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 CONCORDE CURVE SYSTEM?

The FDA product code for CONCORDE CURVE SYSTEM is MAX.

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Other records listing Johnson & 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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