SCARLET® AC-Ti

Q: When was SCARLET® AC-Ti cleared by the FDA?

SCARLET® AC-Ti (K240699) received a 510(k) decision of Substantially Equivalent on May 10, 2024, 57 days after the submission was received.

Q: What is the product code of K240699?

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) K240699 · Spineart SA

Substantially Equivalent

510(k) numberK240699

Submission

Device name: SCARLET® AC-Ti
Applicant: Spineart SA
Plan-Les-Ouates, CH
Received: March 14, 2024
Decision date: May 10, 2024
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

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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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K254158	SPINEART Navigation Instrument SystemOLO · Special	04/09/2026SE
K242933	SPINEART Navigation Instrument SystemOLO · Traditional	06/18/2025SE
K242890	SPINEART Navigation Instrument SystemOLO · Traditional	03/07/2025SE
K242589	Scarlet® AL-TMAX · Traditional	10/23/2024SE
K241644	SPINEART Navigation Instrument SystemOLO · Special	08/07/2024SE
K241321	Juliet® Ti LL Lumbar Interbody DeviceOVD · Traditional	07/18/2024SE

Questions and answers

When was SCARLET® AC-Ti cleared by the FDA?

SCARLET® AC-Ti (K240699) received a 510(k) decision of Substantially Equivalent on May 10, 2024, 57 days after the submission was received.

What is the product code of K240699?

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.