Cleared Special

SPEED TRIAD

K133844 · Biomedical Ent., Inc. · Orthopedic
Apr 2014
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K133844 is an FDA 510(k) clearance for the SPEED TRIAD, 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 April 7, 2014, 110 days after receiving the submission on December 18, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K133844 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2013
Decision Date April 07, 2014
Days to Decision 110 days
Submission Type Special
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

Similar Devices — JDR Staple, Fixation, Bone

All 230
Linkt Compression Staple System
K250712 · Trax Surgical · May 2025
Medline UNITE? REFLEX? Hybrid Nitinol Implant System
K243888 · Medline Industries, LP · Apr 2025
Arthrex DynaNite Nitinol Staples
K243742 · Arthrex, Inc. · Jan 2025
TMC Compression Implant System
K243658 · Treace Medical Concepts · Dec 2024
TMC Compression Implant System
K242415 · Treace Medical Concepts · Sep 2024
COGNiTiON? Staple System
K240212 · Ortho Solutions UK , Ltd. · Feb 2024