Identity
- Trade Name
- Jaw Tracker 4U EUDAMEDNavident FDA UDI
- Generic Name
- Surgical planning/navigation-enhancement system FDA UDI
- Device Name
- Navident Accessory Kit EUDAMEDJaw Tracker 4U FDA UDI
- Model / Reference
- 955-ND-JTUC EUDAMEDFDA UDI
- Description
- Jaw Tracker 4U FDA UDI
Identifiers
- Catalog Number
- 955-ND-JTUC FDA UDI
- Primary DI / UDI-DI
- 07540209955884 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540209955-ND-KITSCP EUDAMED
- Direct Marketing DI
- 07540209955884 EUDAMED
- FDA Product Code
- PLV FDA UDIQRY FDA UDI
- EMDN Code
- Z12011401 SURGICAL NAVIGATION SYSTEM EUDAMED
- GMDN Term
- Surgical planning/navigation-enhancement system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.4120 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: Surgical planning/navigation-enhancement system
Navident by Claronav — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical planning/navigation-enhancement system.
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Cleared under the same submission
K210947 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Claronav
Sources (2)
- FDA UDI e6b01201-2737-4872-a7e5-fa1fbbe21d01 35 fields · synced Jun 19, 2026
- EUDAMED 1165bb1f-47d5-4d7d-9c34-9f4f69e87749 61 fields · synced Jun 19, 2026