Cleared Traditional

THE GRAFTOLOGER

K935753 · Neoligaments, Ltd. · Orthopedic

Apr 1994

Decision

150d

Days

Class 1

Risk

About This 510(k) Submission

K935753 is an FDA 510(k) clearance for the THE GRAFTOLOGER, a Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (Class I — General Controls, product code HWE), submitted by Neoligaments, Ltd. (Leeds, GB). The FDA issued a Cleared decision on April 25, 1994, 150 days after receiving the submission on November 26, 1993. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K935753 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 26, 1993
Decision Date	April 25, 1994
Days to Decision	150 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