Cleared Traditional

K970023 - MEDNEXT SURGICAL BUR
(FDA 510(k) Clearance)

K970023 · Mednext, Inc. · Orthopedic

Feb 1997

Decision

56d

Days

Class 1

Risk

K970023 is an FDA 510(k) clearance for the MEDNEXT SURGICAL BUR, a Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (Class I — General Controls, product code HWE), submitted by Mednext, Inc. (West Palm Beach, US). The FDA issued a Cleared decision on February 28, 1997, 56 days after receiving the submission on January 3, 1997. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K970023 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 03, 1997
Decision Date	February 28, 1997
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement

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