Idys ALIF 3DTi

Q: When was Idys ALIF 3DTi cleared by the FDA?

Idys ALIF 3DTi (K200919) received a 510(k) decision of Substantially Equivalent on April 12, 2021, 371 days after the submission was received.

Q: What is the product code of K200919?

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) K200919 · Clariance

Substantially Equivalent

510(k) numberK200919

Submission

Device name: Idys ALIF 3DTi
Applicant: Clariance
Beaurains, FR
Received: April 6, 2020
Decision date: April 12, 2021
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
K243904	Elegance® Anterior Cervical plateKWQ · Special	01/14/2025SE
K243670	Idys® LIFMAX · Special	12/31/2024SE
K241863	Erisma® Lp Spinal Fixation System; Erisma® LP MISNKB · Special	07/24/2024SE
K240872	Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemNKB · Special	04/26/2024SE
K240715	Idys® C ZP 3DTiOVE · Special	03/22/2024SE
K220182	Aggeris-CKWQ · Traditional	03/30/2022SE
K212562	Idys-C ZP 3DTiOVE · Traditional	10/12/2021SE
K202032	Idys LLIF 3DTiOVD · Traditional	04/01/2021SE
K202956	Erisma LP Navigated InstrumentsOLO · Traditional	02/26/2021SE
K200920	Idys ALIF ZP 3DTiMAX · Special	05/29/2020SE

Questions and answers

When was Idys ALIF 3DTi cleared by the FDA?

Idys ALIF 3DTi (K200919) received a 510(k) decision of Substantially Equivalent on April 12, 2021, 371 days after the submission was received.

What is the product code of K200919?

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.