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OrthoPediatrics PediNail Intramedullary Nailing System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 10-1500-103Model 00-1500-6530
Identity
- Trade Name
- ORTHOPEDIATRICS® PEDINAIL™ INTRAMEDULLARY NAILING SYSTEM EUDAMEDOrthoPediatrics PediNail Intramedullary Nailing System FDA UDI
- Generic Name
- Femur intramedullary nail FDA UDI
- Device Name
- ORTHOPEDIATRICS® PEDINAIL™ INTRAMEDULLARY NAILING SYSTEM EUDAMEDIM FEMORAL NAIL, 10mm x 34cm, Left FDA UDI
- Model / Reference
- 10-1500-103 EUDAMEDFDA UDI00-1500-6530 EUDAMED
- Description
- IM FEMORAL NAIL, 10mm x 34cm, Left FDA UDI
Identifiers
- Catalog Number
- 10-1500-103 FDA UDI
- Primary DI / UDI-DI
- 00841132119303 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841132115002S EUDAMED
- 510(k) Number
- K083726 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Femur intramedullary nail
OrthoPediatrics PediNail Intramedullary Nailing System by Orthopediatrics Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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
K083726 also covers:
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
- OrthoPediatrics PediNail Intramedullary Nailing System — ORTHOPEDIATRICS CORP.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 7e11c614-ab30-4747-b66a-ac0e9d391ba9 36 fields · synced Oct 11, 2026
- EUDAMED ecd2bf60-3304-4971-842f-0a60600cc215 61 fields · synced Oct 10, 2026