HIGH V+— 510(k) K161114

Clearance details

Applicant

Teknimed Sas

Product code

Code NDN

Device class

Class 2

Regulation

21 CFR 888.3027

Advisory panel

Orthopedic

Date received

2016-04-20

Decision date

2017-04-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

L'Union, FR

• K251896 — XeliteMed SuperM-Fix Spinal Bone Cement2026-01-28
• K250637 — VCFix Spinal System2025-05-30
• K243537 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement System2025-04-11
• K241775 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement2024-09-18
• K232842 — Balloon Inflation System2024-02-29

• K242216 — GENTAFIX® (1, 3, 3MV)2024-12-18
• K103816 — COHESION BONE CEMENT2011-02-04

Death

24

Injury

407

Malfunction

1,975

Total

2,406

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-1099-2023 — HIGH V+ Spinal Cement System REF T040321KClass II·Ongoing·TEKNIMED SAS·20221215

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161114.