# Orthopediatrics, Corp (specification developer, Warsaw, IN): 5 new FDA device listings, incl. file

**Score:** 95/100

| Field | Value |
|---|---|
| Establishment | Orthopediatrics, Corp |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Repack or Relabel Medical Device; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Warsaw, IN, US |
| New listings | 5 |
| Devices | File; Plate, Fixation, Bone; Screw, Fixation, Bone; Rod, Fixation, Intramedullary And Accessories; Elevator, Surgical, General & Plastic Surgery |
| Product codes | HTP, HRS, HWC, HSB, GEG |
| Device classes | Class I, Class II |
| Medical specialties | Orthopedic, General, Plastic Surgery |
| Brand names | File; OrthoPediatrics® Locking Cannulated Blade Plate System; Pediatric Nailing Platform Femur; Periosteal Elevator |
| First new listing | 2026-05-08 |
| Latest new listing | 2026-09-28 |
| FDA registration number | 3006460162 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.