Cleared Traditional

K905380 - 1-CUT ACL GRAFT KNIFE
(FDA 510(k) Clearance)

K905380 · Depuy, Inc. · General & Plastic Surgery

Dec 1990

Decision

13d

Days

Class 1

Risk

K905380 is an FDA 510(k) clearance for the 1-CUT ACL GRAFT KNIFE. This device is classified as a Scalpel, One-piece (Class I — General Controls, product code GDX).

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 13, 1990, 13 days after receiving the submission on November 30, 1990.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K905380 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 30, 1990
Decision Date	December 13, 1990
Days to Decision	13 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—