SKELTEX ISV— 510(k) K091234

Name: FDA 510(k) clearance K091234
Creator: U.S. Food and Drug Administration
Published: 2010-02-16

Substantially Equivalent

Skeltex Technologies, Inc.

FDA 510(k) clearance K091234 for SKELTEX ISV, Substantially Equivalent on 2010-02-16. Applicant: Skeltex Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Skeltex Technologies, Inc.
Product code: Code NDN
Device class: Class 2
Regulation: 21 CFR 888.3027
Advisory panel: Orthopedic
Date received: 2009-04-27
Decision date: 2010-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boucherville, Quebec, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code NDN

view all

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

Adverse events under product code NDN

product code NDN

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.