Cleared Traditional

JAWS Nitinol Staple System

K230550 · Paragon 28, Inc. · Orthopedic
May 2023
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K230550 is an FDA 510(k) clearance for the JAWS Nitinol Staple System, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on May 11, 2023, 72 days after receiving the submission on February 28, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K230550 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2023
Decision Date May 11, 2023
Days to Decision 72 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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