Cleared Traditional

EMS SWISS ORTHOCLAST

K991588 · (Ems Sa) Electro Medical Systems · Orthopedic

Jul 1999

Decision

75d

Days

Class 1

Risk

About This 510(k) Submission

K991588 is an FDA 510(k) clearance for the EMS SWISS ORTHOCLAST, a Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (Class I — General Controls, product code HSZ), submitted by (Ems Sa) Electro Medical Systems (North Attleboro, US). The FDA issued a Cleared decision on July 21, 1999, 75 days after receiving the submission on May 7, 1999. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K991588 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 07, 1999
Decision Date	July 21, 1999
Days to Decision	75 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