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

Name: FDA 510(k) clearance K234119
Creator: U.S. Food and Drug Administration
Published: 2024-04-19

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.. Device class: 2.

Clearance details

Applicant: Innosys Co., Ltd.
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
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 ↗

Recent devices under product code OVE

view all

K261882 — Pisces-SC Standalone Cervical Interbody System2026-08-21
K261451 — ZSAlign Cervical Interbody System2026-07-31
K262094 — E3D-C Interbody System2026-07-22
K261279 — DeltaNEC Interbody System2026-06-22
K252982 — CONDUIT ZERO-P VA Secured Spacer System2026-06-18

More clearances from Innosys Co., Ltd.

view all

K241082 — INNOVERSE Navigation Instruments2024-06-14
K233960 — INNOVERSE Spinal System2024-02-06
K231737 — ANAX 5.5 Spinal System2023-10-26

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.