Unispace SA Cervical Cage— 510(k) K213791

Substantially Equivalent

Edisoninno Co., Ltd.

FDA 510(k) clearance K213791 for Unispace SA Cervical Cage, Substantially Equivalent on 2022-08-05. Applicant: Edisoninno Co., Ltd..

Clearance details

Applicant: Edisoninno Co., Ltd.
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2021-12-06
Decision date: 2022-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uijeongbu-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.