HERBERT ULNAR HEAD PROSTHESIS SYSTEM— 510(k) K042902

Name: FDA 510(k) clearance K042902
Creator: U.S. Food and Drug Administration
Published: 2004-12-27

Substantially Equivalent

Stuckenbrock Medizintechnik GmbH

FDA 510(k) clearance K042902 for HERBERT ULNAR HEAD PROSTHESIS SYSTEM, Substantially Equivalent on 2004-12-27. Applicant: Stuckenbrock Medizintechnik GmbH. Device class: 2.

Clearance details

Applicant: Stuckenbrock Medizintechnik GmbH
Product code: Code KXE
Device class: Class 2
Regulation: 21 CFR 888.3810
Advisory panel: Orthopedic
Date received: 2004-10-20
Decision date: 2004-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXE

view all

K190599 — Aptis Medical Distal Radio Ulnar Joint Implant2019-05-03
K142569 — Aptis Medical Distal Radio Ulnar Joint Implant2015-04-03
K112481 — FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT2012-04-09
K081025 — ISOELASTICU2008-11-21
K082839 — DISTAL RADIO-ULNAR JOINT IMPLANT2008-10-24

More clearances from Stuckenbrock Medizintechnik GmbH

view all

K171624 — IXOS Radius Plate System2018-03-29
K171628 — HBS2 Headless Bone Screw2018-01-12

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