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510(k) K252600

Pediatric Plating Platform I Small-Mini by OrthoPediatrics Corp. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2025
Date Received
August 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by OrthoPediatrics Corp.

  • K251362 — PediFlex™ Flexible Nail System (June 24, 2025)
  • K243963 — Pediatric Plating Platform Hip (April 29, 2025)
  • K250623 — Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur (April 1, 2025)
  • K241816 — VerteGlide Spinal Growth Guidance System (March 14, 2025)
  • K243798 — Orthex External Fixation System (March 7, 2025)
  • K233105 — RESPONSE™ Rib and Pelvic System (January 20, 2024)
  • K231266 — Pediatric Nailing Platform Tibia (August 21, 2023)
  • K222105 — RESPONSE 5.5/6.0 Cannulated Screw System (March 23, 2023)
  • K223786 — Orthex External Fixation System (February 10, 2023)
  • K220679 — Pediatric Nailing Platform Femur (July 20, 2022)

Other clearances for product code HRS

  • K253906 — Xpert Hand (March 11, 2026)
  • K260069 — DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (March 9, 2026)
  • K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (March 3, 2026)
  • K254054 — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (March 2, 2026)
  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
  • K252166 — RIB LINK™ Fixation System (February 26, 2026)
  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
  • K251732 — Wrist Fracture System (February 12, 2026)
  • K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System (January 21, 2026)
  • K254002 — TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13 (January 15, 2026)