Nanovis Intervertebral Body Fusion System and Forticore(R)

Q: What is the product code of K161485?

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) K161485 · Nanovis, LLC

Substantially Equivalent

510(k) numberK161485

Submission

Device name: Nanovis Intervertebral Body Fusion System and Forticore(R)
Applicant: Nanovis, LLC
Columbia City, IN, US
Received: May 31, 2016
Decision date: September 6, 2016
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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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
K241605	Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System…MAX · Traditional	09/05/2024SE
K230936	Anatomic PEEK Cervical Fusion System with NanotechnologyODP · Traditional	06/02/2023SE
K203452	Nano FortiFix® SystemNKB · Special	12/22/2020SE
K191822	Nano FortiCore, FortiCoreODP · Traditional	10/11/2019SE
K171312	FortiCore®MAX · Traditional	01/22/2018SE
K160874	Nanovis Intervertebral Body Fusion System and FortiCore®MAX · Special	06/28/2016SE
K140280	ForticoreODP · Traditional	09/05/2014SE
K113173	Nanovis Spinal SystemNKB · Traditional	01/19/2012SE
K110442	Nanovis Intervertebral Body Fusion SystemODP · Traditional	11/09/2011SE

Questions and answers

When was Nanovis Intervertebral Body Fusion System and Forticore(R) cleared by the FDA?

Nanovis Intervertebral Body Fusion System and Forticore(R) (K161485) received a 510(k) decision of Substantially Equivalent on September 6, 2016, 98 days after the submission was received.

What is the product code of K161485?

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.