Stalif Cti, Stalif C

Q: What is the product code of K142079?

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) K142079 · Centinel Spine, Inc.

Substantially Equivalent

510(k) numberK142079

Submission

Device name: Stalif Cti, Stalif C
Applicant: Centinel Spine, Inc.
Washington, DC, US
Received: July 31, 2014
Decision date: October 24, 2014
Decision: Substantially Equivalent (SESE)
Type: Traditional 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
K250554	prodisc® L InstrumentsQLQ · Traditional	04/25/2025SE
K242869	prodisc® L InstrumentsQLQ · Traditional	12/17/2024SE
K221848	prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsQLQ · Traditional	08/19/2022SE
K173347	STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…MAX · Traditional	05/08/2018SE
K152211	PCT SystemNKG · Traditional	12/01/2015SE
K150053	STALIF C; STALIF C-TiOVE · Traditional	06/24/2015SE
K150643	Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiOVD · Traditional	06/08/2015SE
K141942	Midline II TiOVD · Traditional	11/07/2014SE
K133200	Stalif C(R)OVE · Traditional	05/08/2014SE
K133286	Midline (TM)OVD · Special	01/09/2014SE

Questions and answers

When was Stalif Cti, Stalif C cleared by the FDA?

Stalif Cti, Stalif C (K142079) received a 510(k) decision of Substantially Equivalent on October 24, 2014, 85 days after the submission was received.

What is the product code of K142079?

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.