Identity
- Trade Name
- Expert Tibia Nail FDA UDI
- Generic Name
- Tibia intramedullary nail FDA UDI
- Device Name
- Expert Tibia Nail Ø11mm x Length 375mm, Titanium FDA UDI
- Model / Reference
- TI-520-11-375 FDA UDI
- Description
- Expert Tibia Nail Ø11mm x Length 375mm, Titanium FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08903993374566 FDA UDI
- 510(k) Number
- K192003 FDA UDI
- FDA Product Code
- JDS FDA UDI
- GMDN Term
- Tibia intramedullary nail FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Tibia intramedullary nail
Expert Tibia Nail by Auxein Medical Private Limited — 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
- ESTREMO — Citieffe · Class II
- PNP Tibia — ORTHOPEDIATRICS CORP. · Class II
- PNP Tibia — ORTHOPEDIATRICS CORP. · Class II
Cleared under the same submission
K192003 also covers:
- 130° Ga-mma Nail — Auxein Medical Private Limited
- 130° Ga-mma Nail — Auxein Medical Private Limited
- 130° Ga-mma Nail — Auxein Medical Private Limited
- 130° Ga-mma Nail — Auxein Medical Private Limited
- 130° Ga-mma Nail — Auxein Medical Private Limited
- 130° Ga-mma Nail — Auxein Medical Private Limited
- 130° Ga-mma Nail — Auxein Medical Private Limited
- 130° Ga-mma Nail — Auxein Medical Private Limited
- AJAX Nail — Auxein Medical Private Limited
- AJAX Nail — Auxein Medical Private Limited
- AJAX Nail — Auxein Medical Private Limited
- AJAX Nail — Auxein Medical Private Limited
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
- Auxein Medical Private Limited
Sources (1)
- FDA UDI 5476f863-2a00-414a-bbf8-793bf3a4f67d 35 fields · synced Jun 8, 2026