UNiD Patient-matched PLIF cage

Q: What is the product code of K182158?

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) K182158 · Medicrea International SA

Substantially Equivalent

510(k) numberK182158

Submission

Device name: UNiD Patient-matched PLIF cage
Applicant: Medicrea International SA
Rillieux-La-Pape, FR
Received: August 9, 2018
Decision date: July 15, 2019
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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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.

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K213281	PASS LP Spinal System, CD Horizon Spinal SystemNKB · Traditional	01/05/2022SE
K210470	C-CURVE Interbody Fusion DeviceOVE · Traditional	09/03/2021SE
K200316	UNiD IB3D ALIFMAX · Traditional	10/30/2020SE
K191134	IB3D AlifMAX · Traditional	10/30/2019SE
K190092	UNiD Patient specific 3D printed TLIF cageMAX · Traditional	05/08/2019SE
K190376	PASS LP Spinal SystemNKB · Traditional	05/02/2019SE

Questions and answers

When was UNiD Patient-matched PLIF cage cleared by the FDA?

UNiD Patient-matched PLIF cage (K182158) received a 510(k) decision of Substantially Equivalent on July 15, 2019, 340 days after the submission was received.

What is the product code of K182158?

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.