Velofix SA Cervical Cage— 510(k) K172424

Clearance details

Applicant

U&I Corporation

Product code

Code OVE

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2017-08-10

Decision date

2017-11-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Uijeongbu-Si, KR

• 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

• K220147 — Aspiron S ACP System2022-02-16
• K210573 — Velofix SA Cervical Cage2021-11-19
• K183243 — Velofix TLIF Cage2019-07-10
• K190067 — Velofix Interbody Fusion System2019-02-04
• K190053 — SECULOK ACP System2019-02-01

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 →

• Z-1823-2020 — Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level from C2-C3 disc to the C7-T1 disc. Each product is composed of four components: PEEK cage, titanium plate, and two titanium markers.Class II·Terminated·U&I CORP.·20190130

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172424.