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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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