Pediatric Plating Platform I Small-Mini— 510(k) K252600

Name: FDA 510(k) clearance K252600
Creator: U.S. Food and Drug Administration
Published: 2025-10-09

Substantially Equivalent

OrthoPediatrics Corp.

FDA 510(k) clearance K252600 for Pediatric Plating Platform I Small-Mini, Substantially Equivalent on 2025-10-09. Applicant: OrthoPediatrics Corp.. Device class: 2.

Clearance details

Applicant: OrthoPediatrics Corp.
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2025-08-18
Decision date: 2025-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

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K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
K262537 — Versalock Sterile Plating System2026-08-19
K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261511 — Xpert Ankle2026-07-28
K261406 — Versalock Proximal Tibial Plating System2026-07-21

More clearances from OrthoPediatrics Corp.

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K260323 — OrthoPediatrics® Locking Cannulated Blade Plate System2026-04-30
K251362 — PediFlex Flexible Nail System2025-06-24
K243963 — Pediatric Plating Platform Hip2025-04-29
K250623 — Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur2025-04-01
K241816 — VerteGlide Spinal Growth Guidance System2025-03-14

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.