Cleared Traditional

FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM

K913461 · Neoligaments, Ltd. · Orthopedic
Oct 1991
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K913461 is an FDA 510(k) clearance for the FASTLOK (STAPLE & 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 October 15, 1991, 71 days after receiving the submission on August 5, 1991. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K913461 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 1991
Decision Date October 15, 1991
Days to Decision 71 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

Device Classification

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

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