DISTAL RADIO-ULNAR JOINT IMPLANT— 510(k) K082839

Name: FDA 510(k) clearance K082839
Creator: U.S. Food and Drug Administration
Published: 2008-10-24

Substantially Equivalent

Aptis Medical, LLC

FDA 510(k) clearance K082839 for DISTAL RADIO-ULNAR JOINT IMPLANT, Substantially Equivalent on 2008-10-24. Applicant: Aptis Medical, LLC. Device class: 2.

Clearance details

Applicant: Aptis Medical, LLC
Product code: Code KXE
Device class: Class 2
Regulation: 21 CFR 888.3810
Advisory panel: Orthopedic
Date received: 2008-09-26
Decision date: 2008-10-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Glenview, KY, 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
K061146 — SBI ULNAR HEAD IMPLANT2006-07-19

More clearances from Aptis Medical, LLC

view all

K053119 — DISTAL RADIO-ULNAR JOINT IMPLANT2005-12-07
K040497 — DISTAL RADIO-ULNAR JOINT IMPLANT2005-01-26

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