IdentiTi II Cervical Interbody System

Q: What is the product code of K251080?

The FDA product code is ODP – Intervertebral Fusion Device With Bone Graft, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.

FDA 510(k) K251080 · Alphatec Spine, Inc.

Substantially Equivalent

510(k) numberK251080

Submission

Device name: IdentiTi II Cervical Interbody System
Applicant: Alphatec Spine, Inc.
Carlsbad, CA, US
Received: April 8, 2025
Decision date: July 3, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: ODP – Intervertebral Fusion Device With Bone Graft, Cervical
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3080
Specialty: Orthopedic
Implant: Yes

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other 510(k)s with product code ODP

510(k)	Device	Applicant	Decision
K262595	VariLift-C Cervical Interbody Fusion SystemODP · Special	Wenzel Spine, Inc.	08/26/2026SE
K262489	BluEX Cervical Expandable Cage SystemODP · Special	L&K BIOMED Co., Ltd.	08/18/2026SE
K253041	3d Cage CervicalODP · Traditional	Fims Co., Ltd.	07/23/2026SE
K262061	Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special	Stryker Spine	07/17/2026SE
K254130	C.A. Medical Interbody Fusion SystemODP · Special	C.A. Medical, LLC	07/08/2026SE
K260840	BluEX Cervical Expandable Cage SystemODP · Traditional	L&K BIOMED Co., Ltd.	05/16/2026SE
K260850	Osteomni Spinal Cages SystemODP · Traditional	Osteomni, Inc.	05/12/2026SE
K260549	ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemODP · Special	Zsfab, Inc.	04/24/2026SE
K253260	ORIO-3D Cage SystemODP · Traditional	SpineCraft	04/16/2026SE
K260340	HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC…ODP · Traditional	HC Biologics, LLC	04/13/2026SE

More from HC Biologics, LLC

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
K243461	Calibrate Interbody Systems · Traditional	03/04/2025SE
K241375	IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…MAX · Traditional	02/03/2025SE
K242364	IdentiTi II Interbody SystemMAX · Traditional	10/04/2024SE

Questions and answers

When was IdentiTi II Cervical Interbody System cleared by the FDA?

IdentiTi II Cervical Interbody System (K251080) received a 510(k) decision of Substantially Equivalent on July 3, 2025, 86 days after the submission was received.

What is the product code of K251080?

The FDA product code is ODP – Intervertebral Fusion Device With Bone Graft, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.