Pathway Elif

Q: When was Pathway Elif cleared by the FDA?

Pathway Elif (K143143) received a 510(k) decision of Substantially Equivalent on July 22, 2015, 261 days after the submission was received.

Q: What is the product code of K143143?

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) K143143 · Custom Spine, Inc.

Substantially Equivalent

510(k) numberK143143

Submission

Device name: Pathway Elif
Applicant: Custom Spine, Inc.
Parsippany, NJ, US
Received: November 3, 2014
Decision date: July 22, 2015
Decision: Substantially Equivalent (SESE)
Type: Traditional 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.

Other 510(k)s with product code MAX

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K261049	Scala® TLMAX · Traditional	Spineart SA	08/20/2026SE
K261430	TruLift Expandable SystemMAX · Traditional	Life Spine, Inc.	07/28/2026SE
K253011	Catalyft PL Expandable Interbody SystemMAX · Traditional	Medtronic Sofamor Danek USA, Inc.	07/17/2026SE
K261020	Symmetrix L Spinal SystemMAX · Traditional	Medtronic Sofamor Danek USA, Inc.	07/14/2026SE
K253420	Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional	SeaSpine Orthopedics Corporation	07/01/2026SE
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.

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K120597	KompredaMRW · Traditional	05/03/2013SE
K111726	Pathway AvidMAX · Traditional	02/06/2012SE
K111774	Pathway Model 07XXXXMAX · Special	07/20/2011SE
K111099	Issys LP Spinal Fixation SystemNKB · Special	05/05/2011SE
K101151	Regent Anterior Cervical PlateKWQ · Special	05/19/2010SE
K092904	Pathway Ivb/VbrODP · Traditional	12/22/2009SE
K091134	Custom Spine Regent Anterior Cervical PlateKWQ · Traditional	08/17/2009SE
K090566	Pathway AvidMAX · Traditional	06/01/2009SE
K080281	PathwayMAX · Traditional	05/01/2008SE

Questions and answers

When was Pathway Elif cleared by the FDA?

Pathway Elif (K143143) received a 510(k) decision of Substantially Equivalent on July 22, 2015, 261 days after the submission was received.

What is the product code of K143143?

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.