IdentiTi ALIF Standalone Interbody System

Q: What is the product code of K203742?

The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.

FDA 510(k) K203742 · Alphatec Spine, Inc.

Substantially Equivalent

510(k) numberK203742

Submission

Device name: IdentiTi ALIF Standalone Interbody System
Applicant: Alphatec Spine, Inc.
Carlsnad, CA, US
Received: December 22, 2020
Decision date: April 9, 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: OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3080
Specialty: Orthopedic
Implant: Yes

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other 510(k)s with product code OVD

510(k)	Device	Applicant	Decision
K262025	Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional	INNO Holdings Inc. DBA Innovasis	09/11/2026SE
K261408	SABER-XA SystemOVD · Traditional	Elevation Spine	08/03/2026SE
K261809	Interwedge® Standalone LateralOVD · Special	Foundation Surgical Group	07/31/2026SE
K261353	Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional	Kyocera Medical Technologies, Inc.	07/15/2026SE
K260810	Anteralign LS coverplateOVD · Traditional	Tyber Medical, LLC	06/10/2026SE
K254202	MectaLIF 3D Metal AnteriorOVD · Traditional	Medacta International S.A.	05/05/2026SE
K253401	SCRIPT Implant SystemOVD · Traditional	Globus Medical, Inc.	04/29/2026SE
K253559	Ventana A Anterior Lumbar Interbody SystemOVD · Traditional	Spinal Elements, Inc.	02/25/2026SE
K251829	DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional	Degen Medical	12/08/2025SE
K251575	IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional	Alphatec Spine	09/03/2025SE

More from Alphatec Spine

510(k)	Device	Decision
K261284	Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemNKB · Traditional	07/14/2026SE
K253216	IntraOp Alignment System; CONTOUR3D Bending SystemSIN · Traditional	06/25/2026SE
K253615	Invictus Bands SystemOWI · Traditional	03/25/2026SE
K252597	Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…OLO · Traditional	02/19/2026SE
K252842	SafeOp 3: Neural Informatix SystemGWF · Traditional	01/11/2026SE
K251575	IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional	09/03/2025SE
K251965	Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)KWQ · Traditional	08/28/2025SE
K251080	IdentiTi II Cervical Interbody SystemODP · Traditional	07/03/2025SE
K243461	Calibrate Interbody Systems · Traditional	03/04/2025SE
K241375	IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…MAX · Traditional	02/03/2025SE

Questions and answers

When was IdentiTi ALIF Standalone Interbody System cleared by the FDA?

IdentiTi ALIF Standalone Interbody System (K203742) received a 510(k) decision of Substantially Equivalent on April 9, 2021, 108 days after the submission was received.

What is the product code of K203742?

The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.