Identity
- Trade Name
- 611 - ANKLE FUSION NAIL FDA UDI
- Generic Name
- Arthrodesis intramedullary nail, non-distracting FDA UDI
- Model / Reference
- LJU603 FDA UDI
Identifiers
- Catalog Number
- LJU603 FDA UDI
- Primary DI / UDI-DI
- 03700386938290 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Arthrodesis intramedullary nail, non-distracting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Angle — 11 degree FDA UDILength — 180 Millimeter FDA UDIOuter Diameter — 10 Millimeter FDA UDI
611 - Ankle Fusion Nail by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Tornier, Inc.
Sources (1)
- FDA UDI 035a0aa9-2f81-4328-801e-8831b2c726f4 36 fields · synced Jun 6, 2026