Cleared Traditional

SnapShot Fixation System

K143037 · Biomet Manufacturing Corp · Orthopedic
Jan 2015
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K143037 is an FDA 510(k) clearance for the SnapShot Fixation System, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on January 20, 2015, 90 days after receiving the submission on October 22, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K143037 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 2014
Decision Date January 20, 2015
Days to Decision 90 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

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