Impix Spacer

Q: When was Impix Spacer cleared by the FDA?

Impix Spacer (K072226) received a 510(k) decision of Substantially Equivalent on December 10, 2007, 122 days after the submission was received.

Q: What is the product code of K072226?

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) K072226 · Medicrea Technologies

Substantially Equivalent

510(k) numberK072226

Submission

Device name: Impix Spacer
Applicant: Medicrea Technologies
Round Rock, TX, US
Received: August 10, 2007
Decision date: December 10, 2007
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

510(k)	Device	Applicant	Decision
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.

510(k)	Device	Decision
K102406	Pass Anterior Spinal SystemKWQ · Traditional	08/23/2011SE
K100544	Impix Lumbar Interbody DeviceMAX · Special	07/22/2010SE
K083798	Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar IbfMAX · Traditional	05/19/2010SE
K100297	Pass LP Spinal SystemMNI · Traditional	03/04/2010SE
K083810	Pass LP Spinal SystemMNI · Special	07/31/2009SE
K083308	Pass LP Spinal SystemMNI · Special	12/10/2008SE
K082577	Pass LP Spinal SystemMNH · Special	10/03/2008SE
K082069	Pass 2 Spinal SystemMNI · Special	10/03/2008SE
K080099	Pass Spinal SystemMNI · Special	04/09/2008SE
K070530	Modification to Passmed Spinal SystemMNH · Special	10/18/2007SE

Questions and answers

When was Impix Spacer cleared by the FDA?

Impix Spacer (K072226) received a 510(k) decision of Substantially Equivalent on December 10, 2007, 122 days after the submission was received.

What is the product code of K072226?

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.