Identity
- Trade Name
- PedFlex Flexible Nailing System FDA UDI
- Generic Name
- Femur intramedullary nail FDA UDI
- Device Name
- PediFlex clamp SS, 3.0mm left FDA UDI
- Model / Reference
- 00-1001-0531 FDA UDI
- Description
- PediFlex clamp SS, 3.0mm left FDA UDI
Identifiers
- Catalog Number
- 00-1001-0531 FDA UDI
- Primary DI / UDI-DI
- 00840194405768 FDA UDI
- FDA Product Code
- HTY FDA UDI
- GMDN Term
- Femur intramedullary nail FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Femur intramedullary nail
PedFlex Flexible Nailing System by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — 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
K201838 also covers:
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
K251362 also covers:
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
- PedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- FDA UDI d5810beb-7fc1-4715-9291-9110e59da76b 36 fields · synced Jun 1, 2026