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FDA 510(k)

DEXA-C Cervical Interbody System

K-Number: K210521 · 2021-08-02

ApplicantAurora Spine, Inc.
Decision Date2021-08-02
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEXA-C Cervical Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Aurora Spine, Inc.. It received FDA 510(k) clearance on 2021-08-02 under 510(k) number K210521. 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 DEXA-C Cervical Interbody System?

DEXA-C Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2021-08-02. The listed applicant is Aurora Spine, Inc.. The 510(k) number is K210521.

When did DEXA-C Cervical Interbody System receive FDA 510(k) clearance?

DEXA-C Cervical Interbody System received FDA 510(k) clearance on 2021-08-02, under 510(k) number K210521.

Who is the listed applicant for DEXA-C Cervical Interbody System?

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

What is the FDA product code for DEXA-C Cervical Interbody System?

The FDA product code for DEXA-C Cervical Interbody System 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.

NCT05883436Investigation of DEXA-C Anterior Cervical Interbody SystemACTIVE_NOT_RECRUITING

Other records listing Aurora Spine, Inc. 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.

K243865AERO MIS Facet Fusion SystemK221047SILO TFX MIS Sacroiliac Joint Fixation SystemK221399ZIP™ MIS Interspinous Fusion SystemK220610SOLO-LK210325APOLLO Anterior Cervical Plate (ACP) System

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

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

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