DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00— 510(k) K063729

Name: FDA 510(k) clearance K063729
Creator: U.S. Food and Drug Administration
Published: 2007-08-21

Substantially Equivalent

Technomed Europe

FDA 510(k) clearance K063729 for DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00, Substantially Equivalent on 2007-08-21. Applicant: Technomed Europe. Device class: 2.

Clearance details

Applicant: Technomed Europe
Product code: Code GXZ
Device class: Class 2
Regulation: 21 CFR 882.1350
Advisory panel: Neurology
Date received: 2006-12-15
Decision date: 2007-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maastricht-Airport, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code GXZ

view all

K241045 — Disposable Subdermal Needle Electrode, Corkscrew2024-12-11
K232581 — Medical Disposable Sterile Needle Electrode2023-12-04
K231691 — Phantom XL Insulated Dilators2023-06-29
K200984 — Guardian Needle Electrode2020-05-27
K192603 — Spes Medica Subdermal Needle Electrodes2019-11-22

More clearances from Technomed Europe

view all

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