DEXA-C Cervical Interbody System— 510(k) K210521

Substantially Equivalent

Aurora Spine, Inc.

FDA 510(k) clearance K210521 for DEXA-C Cervical Interbody System, Substantially Equivalent on 2021-08-02. Applicant: Aurora Spine, Inc..

Clearance details

Applicant: Aurora Spine, Inc.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2021-02-23
Decision date: 2021-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.