IN:C2 Spinal Fixation System

Q: What is the product code of K122630?

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

FDA 510(k) K122630 · Spine Smith Partners L.P.

Substantially Equivalent

510(k) numberK122630

Submission

Device name: IN:C2 Spinal Fixation System
Applicant: Spine Smith Partners L.P.
Austin, TX, US
Received: August 28, 2012
Decision date: December 5, 2012
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OVE – Intervertebral Fusion Device With Integrated Fixation, 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 with or without supplemental fixation.

Other 510(k)s with product code OVE

510(k)	Device	Applicant	Decision
K261882	Pisces-SC Standalone Cervical Interbody SystemOVE · Traditional	Osseus Fusions Systems, LLC	08/21/2026SE
K261451	ZSAlign Cervical Interbody SystemOVE · Traditional	ZSFab, Inc.	07/31/2026SE
K262094	E3D-C Interbody SystemOVE · Special	Evolution Spine	07/22/2026SE
K261279	DeltaNEC Interbody SystemOVE · Traditional	Nexus Spine	06/22/2026SE
K252982	CONDUIT ZERO-P VA Secured Spacer SystemOVE · Traditional	Avalign Technologies, Inc.	06/18/2026SE
K260036	NeckTune 3D SA Cervical CageOVE · Traditional	Medyssey Co, Ltd.	06/15/2026SE
K260660	SABER-C SystemOVE · Traditional	Elevation Spine	04/27/2026SE
K253213	SAGI Cervical Cage SystemOVE · Traditional	ZheJiang Decans Medical Devices Co., Ltd.	04/20/2026SE
K252774	Uni-C Cervical Cage SystemOVE · Traditional	ZheJiang Decans Medical Devices Co., Ltd.	04/15/2026SE
K260038	E3D-C Interbody SystemOVE · Special	Evolution Spine	02/04/2026SE

More from Evolution Spine

510(k)	Device	Decision
K122168	Visualif Challenging Access PlateOVD · Special	10/11/2012SE
K102090	Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant SystemOVD · Special	09/30/2010SE
K101085	Spinesmith Cynch Spinal SystemMAX · Special	07/01/2010SE
K090376	Spinesmith Cynch Spinal SystemMAX · Traditional	04/01/2009SE
K082821	Spinesmith Partners, LP Cequence Anterior Cervical Plate SystemKWQ · Traditional	10/31/2008SE
K081132	Spinesmith Partners, LP Cequence Anterior Cervical Plate SystemKWQ · Traditional	07/14/2008SE
K080971	Spinesmith Cimplicity Spinal SystemMQP · Traditional	07/02/2008SE
K073320	Cimplicity Spinal SystemODP · Traditional	02/07/2008SE

Questions and answers

When was IN:C2 Spinal Fixation System cleared by the FDA?

IN:C2 Spinal Fixation System (K122630) received a 510(k) decision of Substantially Equivalent on December 5, 2012, 99 days after the submission was received.

What is the product code of K122630?

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