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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 the device name listed in this FDA 510(k) record. The listed applicant is Spineart. It received FDA 510(k) clearance on 2019-03-04 under 510(k) 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. The listed applicant is Spineart. The 510(k) number is K190322.

When did SCARLET® AC-T Secured Anterior Cervical Cage receive FDA 510(k) clearance?

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

Who is the listed applicant for SCARLET® AC-T Secured Anterior Cervical Cage?

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

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

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.

NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITINGNCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATIONNCT07739979Radiological Outcome of Bony Fusion After Single Level Anterior Cervical Discectomy and Fusion Using Iliac Crest Graft vs. Polyetheretherketone Cage in Cervical SpondylosisCOMPLETED

Other records listing Spineart 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: ODP)

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.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.

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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