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FDA 510(k)

SCARLET® AC-T Secured Anterior Cervical Cage

K-Number: K190322 · 2019-03-04

ApplicantSpineart
Decision Date2019-03-04
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SCARLET® AC-T Secured Anterior Cervical Cage is a medical device manufactured by Spineart. It received FDA 510(k) clearance on 2019-03-04 under approval number K190322. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCARLET® AC-T Secured Anterior Cervical Cage?

SCARLET® AC-T Secured Anterior Cervical Cage is a medical device that received FDA 510(k) clearance on 2019-03-04. It is manufactured by Spineart. The 510(k) number is K190322.

When was SCARLET® AC-T Secured Anterior Cervical Cage approved by the FDA?

SCARLET® AC-T Secured Anterior Cervical Cage received FDA 510(k) clearance on 2019-03-04, under approval number K190322.

What company makes SCARLET® AC-T Secured Anterior Cervical Cage?

SCARLET® AC-T Secured Anterior Cervical Cage is manufactured by Spineart.

What is the FDA product code for SCARLET® AC-T Secured Anterior Cervical Cage?

The FDA product code for SCARLET® AC-T Secured Anterior Cervical Cage is ODP.

Related Clinical Trials

NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING NCT04214535 Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels ACTIVE_NOT_RECRUITING

Other Devices by Spineart

K161888JULIET® LL Lateral Lumbar Cage K153621Juliet® Ti K153042TRYPTIK2C-plate Anterior Cervical Plate System K153386Perla Posterior Cervico-Thoracic Fixation system K151104OTELO LL K172065SCARLET AC-T

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Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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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