Identity
- Trade Name
- Pediatric Nailing Platform | Tibia FDA UDI
- Generic Name
- Tibia intramedullary nail FDA UDI
- Device Name
- PNP Tibia 11mm x 260mm Nail FDA UDI
- Model / Reference
- 00-1511-1260 FDA UDI
- Description
- PNP Tibia 11mm x 260mm Nail FDA UDI
Identifiers
- Catalog Number
- 00-1511-1260 FDA UDI
- Primary DI / UDI-DI
- 00840194425759 FDA UDI
- 510(k) Number
- K231266 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Tibia intramedullary nail FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 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: Tibia intramedullary nail
Pediatric Nailing Platform | Tibia by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tibia intramedullary nail.
- Natural Nail® — Zimmer, Inc. · Class II
- Affixus® — Zimmer, Inc. · Class II
- Affixus® — Zimmer, Inc. · Class II
- TRIGEN MAX — Smith & Nephew, Inc. · Class II
- Piccolo Composite Nailing System — CARBOFIX ORTHOPEDICS LTD · Class II
- AJAX Nail — Auxein Medical Private Limited · Class II
- ESTREMO — Citieffe · Class II
- M/DN® — Zimmer, Inc. · Class II
Cleared under the same submission
K231266 also covers:
- Pediatric Nailing Platform | Tibia — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform | Tibia — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform | Tibia — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform | Tibia — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform | Tibia — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform | Tibia — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform | Tibia — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform | Tibia — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform | Tibia — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform | Tibia — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform | Tibia — ORTHOPEDIATRICS CORP.
- Pediatric Nailing Platform | Tibia — 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 |
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Manufacturer
- Manufacturer
- Orthopediatrics Corp.
Sources (1)
- FDA UDI 3bf50c3a-6f20-4d74-be9e-550b5ee0bf7c 35 fields · synced May 30, 2026