Cleared Traditional

MEMOGRAPH STAPLE, WARM SYSTEM

K993714 · Biomedical Ent., Inc. · Orthopedic
Feb 2000
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K993714 is an FDA 510(k) clearance for the MEMOGRAPH STAPLE, WARM 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 February 25, 2000, 115 days after receiving the submission on November 2, 1999. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K993714 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 1999
Decision Date February 25, 2000
Days to Decision 115 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDR — Staple, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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