Cleared Traditional

JAWS Nitinol Staple System

K223056 · Paragon 28, Inc. · Orthopedic
Feb 2023
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K223056 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 February 16, 2023, 139 days after receiving the submission on September 30, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K223056 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2022
Decision Date February 16, 2023
Days to Decision 139 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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