Cleared Traditional

SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM

K043310 · Synthes (Usa) · Orthopedic

Jan 2005

Decision

35d

Days

Class 1

Risk

About This 510(k) Submission

K043310 is an FDA 510(k) clearance for the SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM, a Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (Class I — General Controls, product code HWE), submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on January 5, 2005, 35 days after receiving the submission on December 1, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K043310 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 01, 2004
Decision Date	January 05, 2005
Days to Decision	35 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