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OrthoPediatrics Corp.

FDA 510(k) & PMA Approved Devices — 25 products

Total Devices25
Categories10
Latest FDA decision2026-04-30
TypeNumberDevice NameCodeDateActions
510(k) K260323 OrthoPediatrics® Locking Cannulated Blade Plate SystemHRS2026-04-30 View
510(k) K252600 Pediatric Plating Platform I Small-MiniHRS2025-10-09 View
510(k) K251362 PediFlex™ Flexible Nail SystemHTY2025-06-24 View
510(k) K243963 Pediatric Plating Platform HipHRS2025-04-29 View
510(k) K250623 Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurHSB2025-04-01 View
510(k) K241816 VerteGlide Spinal Growth Guidance SystemPGM2025-03-14 View
510(k) K243798 Orthex External Fixation SystemKTT2025-03-07 View
510(k) K233105 RESPONSE™ Rib and Pelvic SystemMDI2024-01-20 View
510(k) K231266 Pediatric Nailing Platform TibiaHSB2023-08-21 View
510(k) K222105 RESPONSE 5.5/6.0 Cannulated Screw SystemNKB2023-03-23 View
510(k) K223786 Orthex External Fixation SystemKTT2023-02-10 View
510(k) K220679 Pediatric Nailing Platform FemurHSB2022-07-20 View
510(k) K220809 Drive Rail SystemKTT2022-04-08 View
510(k) K203573 RESPONSE Navigation InstrumentsOLO2021-02-04 View
510(k) K201838 PediFlex Flexible Nail SystemHTY2021-01-29 View
510(k) K193100 RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemNKB2020-03-24 View
510(k) K200097 Response BandLoc Spinal FixationOWI2020-03-16 View
510(k) K190321 Pediatric Nailing PlatformFemurHSB2019-10-09 View
510(k) K190992 OrthoPediatrics PediFoot Deformity Corrections SystemHRS2019-08-06 View
510(k) K190324 OrthoPediatrics Cannulated Screw SystemHWC2019-07-05 View

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