Spinesmith Cynch Spinal System

Q: What is the product code of K090376?

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) K090376 · Spine Smith Partners L.P.

Substantially Equivalent

510(k) numberK090376

Submission

Device name: Spinesmith Cynch Spinal System
Applicant: Spine Smith Partners L.P.
Austin, TX, US
Received: February 17, 2009
Decision date: April 1, 2009
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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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.

510(k)	Device	Decision
K122630	IN:C2 Spinal Fixation SystemOVE · Special	12/05/2012SE
K122168	Visualif Challenging Access PlateOVD · Special	10/11/2012SE
K102090	Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant SystemOVD · Special	09/30/2010SE
K101085	Spinesmith Cynch Spinal SystemMAX · Special	07/01/2010SE
K082821	Spinesmith Partners, LP Cequence Anterior Cervical Plate SystemKWQ · Traditional	10/31/2008SE
K081132	Spinesmith Partners, LP Cequence Anterior Cervical Plate SystemKWQ · Traditional	07/14/2008SE
K080971	Spinesmith Cimplicity Spinal SystemMQP · Traditional	07/02/2008SE
K073320	Cimplicity Spinal SystemODP · Traditional	02/07/2008SE

Questions and answers

When was Spinesmith Cynch Spinal System cleared by the FDA?

Spinesmith Cynch Spinal System (K090376) received a 510(k) decision of Substantially Equivalent on April 1, 2009, 43 days after the submission was received.

What is the product code of K090376?

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.