Identity
- Trade Name
- Inion Hexalon instrument FDA UDI
- Generic Name
- Orthopaedic bone screw starter/notcher FDA UDI
- Device Name
- Starter, 8/9 mm FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Starter, 8/9 mm FDA UDI
Identifiers
- Catalog Number
- INS-9206 FDA UDI
- Primary DI / UDI-DI
- M224INS920610 FDA UDI
- 510(k) Number
- K071464 FDA UDI
- FDA Product Code
- JDR FDA UDIHWC FDA UDIMAI FDA UDI
- GMDN Term
- Orthopaedic bone screw starter/notcher FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Inion Hexalon instrument by Inion , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Inion , Ltd.
Sources (1)
- FDA UDI 0b404234-2d59-4de8-a6a5-9afc64436cb0 36 fields · synced Jun 1, 2026