SPIRA-C Open Matrix Cervical Interbody

Q: What is the product code of K172446?

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) K172446 · Camber Spine Technologies

Substantially Equivalent

510(k) numberK172446

Submission

Device name: SPIRA-C Open Matrix Cervical Interbody
Applicant: Camber Spine Technologies
Wayne, PA, US
Received: August 14, 2017
Decision date: November 7, 2017
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
K234077	SPIRA® Anterior Lumbar SpacersMAX · Traditional	07/12/2024SE
K232256	Alcantara Thoracolumbar Plate SystemKWQ · Traditional	04/16/2024SE
K233972	Camber Sacroiliac (SI) Fixation SystemOUR · Traditional	02/27/2024SE
K230942	SPIRA® Posterior Lumbar SpacersMAX · Traditional	07/11/2023SE
K221324	ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)OVD · Traditional	03/30/2023SE
K223837	SPIRA®-C Integrated Fixation SystemOVE · Traditional	03/22/2023SE
K203503	Camber Sacroiliac (SI) Fixation SystemOUR · Traditional	09/02/2022SE
K220038	Camber Spine Navigation SystemOLO · Traditional	04/29/2022SE
K210595	SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersMAX · Traditional	06/15/2021SE
K193153	SPIRA-C Integrated Fixation SystemOVE · Traditional	04/24/2020SE

Questions and answers

When was SPIRA-C Open Matrix Cervical Interbody cleared by the FDA?

SPIRA-C Open Matrix Cervical Interbody (K172446) received a 510(k) decision of Substantially Equivalent on November 7, 2017, 85 days after the submission was received.

What is the product code of K172446?

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.