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Curiteva Navigation System
FDA 510(k)FDA UDIClass II (US FDA 510(k))
510(k) K223200
Identity
- Trade Name
- Curiteva Navigation System FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Cannulated 7mm Screw Inserter, Navigation, SI-LUTION FDA UDI
- Model / Reference
- C645-411 FDA UDI
- Description
- Cannulated 7mm Screw Inserter, Navigation, SI-LUTION FDA UDI
Identifiers
- Primary DI / UDI-DI
- B648C6454110 FDA UDI
- 510(k) Number
- FDA Product Code
- OLO FDA 510(k)FDA UDI
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)FDA UDI
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Curiteva Navigation System by Curiteva, LLC — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223200 | Class II | Active |
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Manufacturer
- Manufacturer
- Curiteva, LLC
- FDA Applicant
- Curiteva, Inc.
Sources (2)
- FDA 510(k) K223200 24 fields · synced Jun 18, 2026
- FDA UDI 49efbd1e-6247-41ea-8c66-59cfaf82a757 35 fields · synced May 27, 2026