InFill Interbody Fusion Devices

Q: What is the product code of K151184?

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) K151184 · Pinnacle Spine Group, LLC

Substantially Equivalent

510(k) numberK151184

Submission

Device name: InFill Interbody Fusion Devices
Applicant: Pinnacle Spine Group, LLC
Dallas, TX, US
Received: May 4, 2015
Decision date: July 14, 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

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
K172349	InFill® Interbody Fusion DeviceMAX · Traditional	12/14/2017SE
K152259	InFill Interbody Fusion DeviceMAX · Traditional	11/19/2015SE
K150206	InFill Interbody Fusion DevicesMAX · Special	04/03/2015SE
K143488	InFill Graft Delivery SystemFMF · Special	12/17/2014SE
K141282	PGS 5.5 MM Cannulated Pedicle ScrewNKB · Traditional	12/02/2014SE
K140066	Infill CervicalODP · Traditional	05/05/2014SE
K133721	Infill 41-TLIF Convex Oblique Device, Infill 43-TLIF Contour Oblique, Infill 44-TLIF…MAX · Traditional	03/31/2014SE
K124012	Infill Oblique Tlif DeviceMAX · Traditional	06/04/2013SE
K121476	Infill Graft Delivery SystemFMF · Special	08/29/2012SE
K121733	Infill Intervertebral Body Fusion DeviceMAX · Special	07/13/2012SE

Questions and answers

When was InFill Interbody Fusion Devices cleared by the FDA?

InFill Interbody Fusion Devices (K151184) received a 510(k) decision of Substantially Equivalent on July 14, 2015, 71 days after the submission was received.

What is the product code of K151184?

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.