Cleared Traditional

MEDNEXT 1000 BONE DISSECTING SYSTEM

K926547 · Mednext, Inc. · Orthopedic

Jul 1993

Decision

203d

Days

Class 1

Risk

About This 510(k) Submission

K926547 is an FDA 510(k) clearance for the MEDNEXT 1000 BONE DISSECTING SYSTEM, a Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (Class I — General Controls, product code HSZ), submitted by Mednext, Inc. (West Point Beach, US). The FDA issued a Cleared decision on July 22, 1993, 203 days after receiving the submission on December 31, 1992. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K926547 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 31, 1992
Decision Date	July 22, 1993
Days to Decision	203 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