Concorde Curve System

Q: What is the product code of K103743?

The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.

FDA 510(k) K103743 · Johnson & Johnson

Substantially Equivalent

510(k) numberK103743

Submission

Device name: Concorde Curve System
Applicant: Johnson & Johnson
Raynham, MA, US
Received: December 23, 2010
Decision date: March 17, 2011
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3080
Specialty: Orthopedic
Implant: Yes

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

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K253151	Fule Interbody Fusion Cage SystemMAX · Traditional	Beijing Fule Science & Technology Development…	06/15/2026SE
K261159	Exceed® Biplanar Expandable Interbody SystemMAX · Traditional	Spine Wave, Inc.	05/29/2026SE
K253894	BMD Titanium Spinal Fusion SystemMAX · Traditional	Global Biomedica s.r.o.	05/28/2026SE
K260506	Ventana® P/T Lumbar Interbody SystemMAX · Traditional	Spinal Elements, Inc.	05/15/2026SE
K260837	VersaLift Expandable SystemMAX · Traditional	Life Spine, Inc.	05/12/2026SE

More from Life Spine, Inc.

510(k)	Device	Decision
K113273	Spotlight Access SystemGZT · Traditional	01/27/2012SE
K112913	Spotlight Access SystemGZT · Special	12/16/2011SE
K113348	Cougar SystemMAX · Special	12/13/2011SE
K110551	Expedium Spine SystemNKB · Special	10/26/2011SE
K110694	Concorde Bullet Spinal SystemMAX · Special	10/11/2011SE
K111571	Viper SystemsNKB · Special	07/06/2011SE
K110454	Cougar LS Lateral Cage SystemMAX · Special	05/13/2011SE
K103490	Expedium Spine System, Moss Miami Spine SystemNKB · Traditional	02/17/2011SE
K063577	Femoral Intrafix Screw and SheathMBI · Traditional	01/25/2007SE
K060914	Trident AnchorHWC · Traditional	06/09/2006SE

Questions and answers

When was Concorde Curve System cleared by the FDA?

Concorde Curve System (K103743) received a 510(k) decision of Substantially Equivalent on March 17, 2011, 84 days after the submission was received.

What is the product code of K103743?

The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.