Identity
- Trade Name
- Stainless Steel Tibial Nailing System FDA UDI
- Generic Name
- Tibia intramedullary nail FDA UDI
- Device Name
- STERILE SOLID TIBIAL NAIL DIAMETER 8 MM LENGTH 360 MM FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- STERILE SOLID TIBIAL NAIL DIAMETER 8 MM LENGTH 360 MM FDA UDI
Identifiers
- Catalog Number
- 99-74836 FDA UDI
- Primary DI / UDI-DI
- 18032568862713 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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 360 Millimeter FDA UDIOuter Diameter — 8 Millimeter FDA UDI
Category: Tibia intramedullary nail
Stainless Steel Tibial Nailing System by Orthofix, Inc. — 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
- PNP Tibia — ORTHOPEDIATRICS CORP. · Class II
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
- Orthofix, Inc.
Sources (1)
- FDA UDI bee2dd3b-f127-483d-a66d-04bc75f1b69b 36 fields · synced Jun 6, 2026