Republic Spine Restore Cervical Interbody Fusion System— 510(k) K190889

Substantially Equivalent

Republic Spine, LLC

FDA 510(k) clearance K190889 for Republic Spine Restore Cervical Interbody Fusion System, Substantially Equivalent on 2019-06-19. Applicant: Republic Spine, LLC.

Clearance details

Applicant: Republic Spine, LLC
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2019-04-05
Decision date: 2019-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, 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.