Cleared Traditional

FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM

K911445 · Neoligaments, Ltd. · Orthopedic
Jun 1991
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K911445 is an FDA 510(k) clearance for the FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Neoligaments, Ltd. (Wakefield, US). The FDA issued a Cleared decision on June 28, 1991, 86 days after receiving the submission on April 3, 1991. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K911445 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1991
Decision Date June 28, 1991
Days to Decision 86 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

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