Identity
- Trade Name
- ICON FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system FDA UDI
- Device Name
- Multi-axial Reduction Body FDA UDI
- Model / Reference
- 68-7000 FDA UDI
- Description
- Multi-axial Reduction Body FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18257200065417 FDA UDI
- 510(k) Number
- K111448 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Icon by Orthofix US LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K111448 also covers:
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 US LLC
Sources (1)
- FDA UDI 79cf7a9f-0893-4067-94dd-8b99e3126869 36 fields · synced Jun 1, 2026