UniSpace® Stand-Alone C Cage— 510(k) K234119

Substantially Equivalent

Innosys Co., Ltd.

FDA 510(k) clearance K234119 for UniSpace® Stand-Alone C Cage, Substantially Equivalent on 2024-04-19. Applicant: Innosys Co., Ltd..

Clearance details

Applicant: Innosys Co., Ltd.
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2023-12-28
Decision date: 2024-04-19
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.