Atlas Intervertebral Body Cage

Q: What is the product code of K092774?

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) K092774 · Spinal Edge, LLC

Substantially Equivalent

510(k) numberK092774

Submission

Device name: Atlas Intervertebral Body Cage
Applicant: Spinal Edge, LLC
Avon, OH, US
Received: September 9, 2009
Decision date: February 2, 2010
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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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
K091110	Spinal Edge Titan Pedicle Screw SystemMNH · Traditional	07/24/2009SE
K060916	Atlas Spinal Cage, Models SC-150-007, 009, 011, 013, 015, 017.MQP · Traditional	06/08/2006SE

Questions and answers

When was Atlas Intervertebral Body Cage cleared by the FDA?

Atlas Intervertebral Body Cage (K092774) received a 510(k) decision of Substantially Equivalent on February 2, 2010, 146 days after the submission was received.

What is the product code of K092774?

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.