ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0— 510(k) K070021

Name: FDA 510(k) clearance K070021
Creator: U.S. Food and Drug Administration
Published: 2007-12-07

Substantially Equivalent

Jg Medical Products, LLC

FDA 510(k) clearance K070021 for ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0, Substantially Equivalent on 2007-12-07. Applicant: Jg Medical Products, LLC. Device class: 2.

Clearance details

Applicant: Jg Medical Products, LLC
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 2007-01-03
Decision date: 2007-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yonkers, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRX

view all

K260203 — Fule Vertebroplasty Balloon Catheter2026-08-28
K254103 — HOPKINS Telescopes for Arthroscopy2026-08-26
K252790 — Digital ClarusScope System and Digital NeuroPEN System2026-05-26
K253523 — Freedom DS Decompression System2026-04-16
K252546 — VantageTM Lumbar Decompression Kit2026-03-12

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.