OrthoPediatrics Corp. - FDA 510(k) Cleared Devices
Recent clearances: OrthoPediatrics® Locking Cannulated Blade Plate System, Pediatric Plating Platform I Small-Mini, PediFlex™ Flexible Nail System
40
Total
38
Cleared
0
Denied
FDA 510(k) Regulatory Record - OrthoPediatrics Corp. Orthopedic ✕
40 devices
Cleared
Apr 30, 2026
OrthoPediatrics® Locking Cannulated Blade Plate System
Orthopedic
90d
Cleared
Oct 09, 2025
Pediatric Plating Platform I Small-Mini
Orthopedic
52d
Cleared
Jun 24, 2025
PediFlex™ Flexible Nail System
Orthopedic
54d
Cleared
Apr 29, 2025
Pediatric Plating Platform Hip
Orthopedic
127d
Cleared
Apr 01, 2025
Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur
Orthopedic
29d
Cleared
Mar 14, 2025
VerteGlide Spinal Growth Guidance System
Orthopedic
263d
Cleared
Mar 07, 2025
Orthex External Fixation System
Orthopedic
86d
Cleared
Jan 20, 2024
RESPONSE™ Rib and Pelvic System
Orthopedic
115d
Cleared
Aug 21, 2023
Pediatric Nailing Platform Tibia
Orthopedic
111d
Cleared
Mar 23, 2023
RESPONSE 5.5/6.0 Cannulated Screw System
Orthopedic
248d
Cleared
Feb 10, 2023
Orthex External Fixation System
Orthopedic
53d
Cleared
Jul 20, 2022
Pediatric Nailing Platform Femur
Orthopedic
134d
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