Cleared Traditional

EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM

K050766 · Zimmer Trabecular · Orthopedic

May 2005

Decision

62d

Days

Class 1

Risk

About This 510(k) Submission

K050766 is an FDA 510(k) clearance for the EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM, a Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (Class I — General Controls, product code HWE), submitted by Zimmer Trabecular (Allendale, US). The FDA issued a Cleared decision on May 26, 2005, 62 days after receiving the submission on March 25, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K050766 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 2005
Decision Date	May 26, 2005
Days to Decision	62 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HWE — Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4820