Cleared Traditional

SODEM HIGH SPEED SYSTEM

K954080 · Sodem Diffusion SA · Orthopedic

Oct 1995

Decision

46d

Days

Class 1

Risk

About This 510(k) Submission

K954080 is an FDA 510(k) clearance for the SODEM HIGH SPEED SYSTEM, a Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (Class I — General Controls, product code HSZ), submitted by Sodem Diffusion SA (North Attleboro, US). The FDA issued a Cleared decision on October 16, 1995, 46 days after receiving the submission on August 31, 1995. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K954080 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 1995
Decision Date	October 16, 1995
Days to Decision	46 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSZ — Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
Device Class	Class I — General Controls
CFR Regulation	21 CFR 878.4820