Cleared Traditional

NITINEX Memory Compression Staple

K231493 · Vilex, LLC · Orthopedic
Aug 2023
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K231493 is an FDA 510(k) clearance for the NITINEX Memory Compression Staple, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Vilex, LLC (Mcminnville, US). The FDA issued a Cleared decision on August 11, 2023, 80 days after receiving the submission on May 23, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K231493 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2023
Decision Date August 11, 2023
Days to Decision 80 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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