Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Aurora Spine, Inc.. It received FDA 510(k) clearance on 2021-08-02 under approval 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. It is manufactured by Aurora Spine, Inc.. The 510(k) number is K210521.

When was DEXA-C Cervical Interbody System approved by the FDA?

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

What company makes DEXA-C Cervical Interbody System?

DEXA-C Cervical Interbody System is manufactured by Aurora Spine, Inc..

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

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT07153536 Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis RECRUITING NCT05305430 Real World Data Collection on the Synergy Cervical Disc RECRUITING

Other Devices by Aurora Spine, Inc.

K210325APOLLO Anterior Cervical Plate (ACP) System K221047SILO TFX MIS Sacroiliac Joint Fixation System K221399ZIP™ MIS Interspinous Fusion System K220610SOLO-L

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.

↑