Identity
- Trade Name
- Cannulated Femur Nail, Left FDA UDI
- Generic Name
- Femur intramedullary nail FDA UDI
- Device Name
- Cannulated Femur Nail, Left, D=10mm, L=420mm FDA UDI
- Model / Reference
- 12210-420 FDA UDI
- Description
- Cannulated Femur Nail, Left, D=10mm, L=420mm FDA UDI
Identifiers
- Catalog Number
- 12210-420 FDA UDI
- Primary DI / UDI-DI
- 09120047304440 FDA UDI
- 510(k) Number
- K132945 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Femur 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
Category: Femur intramedullary nail
Cannulated Femur Nail, Left by I.T.S. GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Femur intramedullary nail.
- GAMMA — Stryker Corp. · Class II
- A.R.T.™FEMORAL NAIL — Biomet Orthopedics, Inc. · Class II
- T2 ALPHA — Stryker Corp. · Class II
- PRECICE® Bone Transport System — NuVasive Specialized Orthopedics, Inc. · Class II
- T2 — Stryker Corp. · Class II
- 130° Ga-mma Nail — Auxein Medical Private Limited · Class II
- ARIX Femur Nail System — Jeil Medical Corporation · Class II
- INTERTAN — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K132945 also covers:
- Cannulated Femur Nail, Left — I.T.S. GmbH
- Cannulated Femur Nail, Left — I.T.S. GmbH
- Cannulated Femur Nail, Left — I.T.S. GmbH
- Cannulated Femur Nail, Left — I.T.S. GmbH
- Cannulated Femur Nail, Left — I.T.S. GmbH
- Cannulated Femur Nail, Left — I.T.S. GmbH
- Cannulated Femur Nail, Left — I.T.S. GmbH
- Cannulated Femur Nail, Right — I.T.S. GmbH
- Cannulated Femur Nail, Right — I.T.S. GmbH
- Cannulated Femur Nail, Right — I.T.S. GmbH
- Cannulated Femur Nail, Right — I.T.S. GmbH
- Cannulated Femur Nail, Right — I.T.S. GmbH
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
- I.T.S. GmbH
Sources (1)
- FDA UDI 3a8a5793-34a6-4b85-855d-9646c7744595 35 fields · synced Jun 8, 2026