Cleared Traditional

MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM

K001354 · Biomedical Ent., Inc. · Orthopedic

Mar 2001

Decision

319d

Days

Class 2

Risk

About This 510(k) Submission

K001354 is an FDA 510(k) clearance for the MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Biomedical Ent., Inc. (San Antonio, US). The FDA issued a Cleared decision on March 13, 2001, 319 days after receiving the submission on April 28, 2000. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K001354 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 2000
Decision Date	March 13, 2001
Days to Decision	319 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF