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FDA 510(k)

SCARLET® AC-Ti

K-Number: K240699 · 2024-05-10

ApplicantSpineart SA
Decision Date2024-05-10
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SCARLET® AC-Ti is the device name listed in this FDA 510(k) record. The listed applicant is Spineart SA. It received FDA 510(k) clearance on 2024-05-10 under 510(k) number K240699. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCARLET® AC-Ti?

SCARLET® AC-Ti is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is Spineart SA. The 510(k) number is K240699.

When did SCARLET® AC-Ti receive FDA 510(k) clearance?

SCARLET® AC-Ti received FDA 510(k) clearance on 2024-05-10, under 510(k) number K240699.

Who is the listed applicant for SCARLET® AC-Ti?

The FDA 510(k) record lists Spineart SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCARLET® AC-Ti?

The FDA product code for SCARLET® AC-Ti is OVE.

Other records listing Spineart SA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262639BAGUERA® C Cervical Disc Surgical InstrumentsK261205SPINEART Navigation Instrument SystemK253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemK254158SPINEART Navigation Instrument SystemK242933SPINEART Navigation Instrument SystemK242890SPINEART Navigation Instrument System

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Related Devices (Code: OVE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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