ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS— 510(k) K073233

Name: FDA 510(k) clearance K073233
Creator: U.S. Food and Drug Administration
Published: 2008-01-28

Substantially Equivalent

Advanced Bio-Surfaces, Inc.

FDA 510(k) clearance K073233 for ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS, Substantially Equivalent on 2008-01-28. Applicant: Advanced Bio-Surfaces, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Bio-Surfaces, Inc.
Product code: Code HSH
Device class: Class 2
Regulation: 21 CFR 888.3590
Advisory panel: Orthopedic
Date received: 2007-11-15
Decision date: 2008-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HSH

view all

K053094 — ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 90562006-02-06
K033242 — KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS)2003-12-31
K022779 — OTI UNICONDULAR INTERPOSITIONAL SPACER2002-11-20
K003269 — UNICONDYLAR INTERPOSITIONAL SPACER2001-01-04

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