FDA 510(k) Applications Submitted by Edward Wells-Spicer

FDA 510(k) Number Submission Date Device Name Applicant
K240594 03/04/2024 Grappler Suture Anchor R3FLEX IOL System Paragon 28, Inc.
K250641 03/04/2025 APEX 3D Total Ankle Replacement System Paragon 28, Inc.
K250952 03/28/2025 Baby Gorilla«/Gorilla« Plating System Paragon 28 Inc
K241262 05/06/2024 Baby Gorilla/Gorilla Plating System; Monster Screw System Paragon 28, Inc.
K251850 06/16/2025 Phantom« Hindfoot TTC/TC Nail System Paragon 28, Inc
K231867 06/26/2023 Grappler Suture Anchor System Paragon 28, Inc.
K241864 06/27/2024 Grappler Interference Screw System Paragon 28, Inc.
K242452 08/19/2024 Monkey Bars Pin to Bar External Fixation System Paragon 28, Inc.
K232838 09/14/2023 Monkey RingsTM External Fixation System Paragon 28, Inc.


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