Chesapeake (Cervical Components)

Q: What is the product code of K111439?

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) K111439 · K2m, Inc.

Substantially Equivalent

510(k) numberK111439

Submission

Device name: Chesapeake (Cervical Components)
Applicant: K2m, Inc.
Leesburg, VA, US
Received: May 24, 2011
Decision date: August 24, 2011
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

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K193129	Yukon OCT Spinal SystemNKG · Traditional	02/07/2020SE
K192911	Brainlab Compatible K2M Navigation InstrumentsOLO · Special	11/14/2019SE
K190179	SAHARA Stabilization SystemOVD · Traditional	10/03/2019SE

Questions and answers

When was Chesapeake (Cervical Components) cleared by the FDA?

Chesapeake (Cervical Components) (K111439) received a 510(k) decision of Substantially Equivalent on August 24, 2011, 92 days after the submission was received.

What is the product code of K111439?

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.