PediNail Intramedullary Platform
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- OrthoPediatrics® Pediatric Nailing Platform|Femur System EUDAMEDPediNail Intramedullary Platform FDA UDI
- Generic Name
- Femur intramedullary nail FDA UDI
- Device Name
- ORTHOPEDIATRICS® PEDINAIL™ INTRAMEDULLARY NAILING SYSTEM EUDAMED5.0MM X 32.5MM FULLY THREADED INTERLOCKING SCREW, 4.3MM CORE FDA UDI
- Model / Reference
- 00-1506-4033 EUDAMEDFDA UDI00-1500-6530 EUDAMED
- Description
- 5.0MM X 32.5MM FULLY THREADED INTERLOCKING SCREW, 4.3MM CORE FDA UDI
Identifiers
- Catalog Number
- 00-1506-4033 FDA UDI
- Primary DI / UDI-DI
- 00841132148907 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841132115002S EUDAMED
- 510(k) Number
- K172583 FDA UDI
- FDA Product Code
- HSB FDA UDI
- EMDN Code
- P09120604 OSTEOSYNTHESIS NAIL-SCREW SYSTEMS EUDAMED
- GMDN Term
- Femur intramedullary nail FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Femur intramedullary nail
PediNail Intramedullary Platform by Orthopediatrics Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Femur intramedullary nail.
- GAMMA — Stryker Corp. · Class II
- A.R.T.™FEMORAL NAIL — Biomet Orthopedics, Inc. · Class II
- T2 ALPHA — Stryker Corp. · Class II
- PRECICE® Bone Transport System — NuVasive Specialized Orthopedics, Inc. · Class II
- T2 — Stryker Corp. · Class II
- 130° Ga-mma Nail — Auxein Medical Private Limited · Class II
- ARIX Femur Nail System — Jeil Medical Corporation · Class II
- INTERTAN — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K172583 also covers:
- PediNail Intramedullary Platform — ORTHOPEDIATRICS CORP.
- PediNail Intramedullary Platform — ORTHOPEDIATRICS CORP.
- PediNail Intramedullary Platform — ORTHOPEDIATRICS CORP.
- PediNail Intramedullary Platform — ORTHOPEDIATRICS CORP.
- PediNail Intramedullary Platform — ORTHOPEDIATRICS CORP.
- PediNail Intramedullary Platform — ORTHOPEDIATRICS CORP.
- PediNail Intramedullary Platform — ORTHOPEDIATRICS CORP.
- PediNail Intramedullary Platform — ORTHOPEDIATRICS CORP.
- PediNail Intramedullary Platform — ORTHOPEDIATRICS CORP.
- PediNail Intramedullary Platform — ORTHOPEDIATRICS CORP.
- PediNail Intramedullary Platform — ORTHOPEDIATRICS CORP.
- PediNail Intramedullary Platform — ORTHOPEDIATRICS CORP.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Orthopediatrics Corp.
Sources (2)
- FDA UDI 8eb03431-a613-4d32-83ee-5e661d165cba 36 fields · synced Oct 10, 2026
- EUDAMED 5c1faf50-8527-4950-86bd-8e42186ade4a 61 fields · synced Oct 10, 2026