Identity
- Trade Name
- ODI Talon™ Intramedullary Hip Nail FDA UDI
- Generic Name
- Orthopaedic implant-instrument extension adaptor, single-use FDA UDI
- Device Name
- Lag Sleeve FDA UDI
- Model / Reference
- THN001 FDA UDI
- Description
- Lag Sleeve FDA UDI
Identifiers
- Primary DI / UDI-DI
- B058THN0011 FDA UDI
- 510(k) Number
- K014189 FDA UDI
- FDA Product Code
- JDS FDA UDI
- GMDN Term
- Orthopaedic implant-instrument extension adaptor, single-use 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
No
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: Orthopaedic implant-instrument extension adaptor, single-use
ODI Talon™ Intramedullary Hip Nail by Orthopedic Designs North America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Orthopedic Designs North America, Inc.
Sources (1)
- FDA UDI 7108d18e-0db9-42ae-b28d-82f0ba79da3c 35 fields · synced May 30, 2026