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PNP Femur
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 00-1501-0728-SModel 00-1500-6530
Identity
- Trade Name
- OrthoPediatrics® Pediatric Nailing Platform|Femur System EUDAMEDPNP Femur FDA UDI
- Generic Name
- Femur intramedullary nail FDA UDI
- Device Name
- ORTHOPEDIATRICS® PEDINAIL™ INTRAMEDULLARY NAILING SYSTEM EUDAMED7mm x 280mm Child Nail, Left FDA UDI
- Model / Reference
- 00-1501-0728-S EUDAMEDFDA UDI00-1500-6530 EUDAMED
- Description
- 7mm x 280mm Child Nail, Left FDA UDI
Identifiers
- Catalog Number
- 00-1501-0728-S FDA UDI
- Primary DI / UDI-DI
- 00841132191859 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841132115002S EUDAMED
- 510(k) Number
- K250623 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Femur intramedullary nail
PNP Femur 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
K250623 also covers:
- PNP Femur — ORTHOPEDIATRICS CORP.
- PNP Femur — ORTHOPEDIATRICS CORP.
- PNP Femur — ORTHOPEDIATRICS CORP.
- PNP Femur — ORTHOPEDIATRICS CORP.
- PNP Femur — ORTHOPEDIATRICS CORP.
- PNP Femur — ORTHOPEDIATRICS CORP.
- PNP Femur — ORTHOPEDIATRICS CORP.
- PNP Femur — ORTHOPEDIATRICS CORP.
- PNP Femur — ORTHOPEDIATRICS CORP.
- PNP Femur — ORTHOPEDIATRICS CORP.
- PNP Femur — ORTHOPEDIATRICS CORP.
- PNP Femur — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthopediatrics Corp.
Sources (2)
- FDA UDI 1ff88a32-d521-4934-89e2-5cbe0197aa6c 36 fields · synced Oct 7, 2026
- EUDAMED 5f2d9189-850a-4a90-9108-e70704c08aba 61 fields · synced Oct 7, 2026