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ExactechGPS Total Ankle Navigation Application
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref L00480
Identity
- Trade Name
- ExactechGPS Total Ankle Navigation Application EUDAMED
- Device Name
- ExactechGPS Total Ankle Navigation Application EUDAMED
- Model / Reference
- L00480 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10885862623638 EUDAMED
- Basic UDI-DI
- 10885862100217P3 EUDAMED
- EMDN Code
- Z12011482 SURGICAL NAVIGATION INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ExactechGPS Total Ankle Navigation Application by Blue Ortho SAS — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152764 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K100742 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K232521 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 10885862100217P3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Blue Ortho SAS
- EUDAMED SRN
- FR-MF-000002436
Sources (2)
- EUDAMED 85c84a79-7b7d-4591-9cda-baf2f3c41472 61 fields · synced Aug 4, 2026
- FDA 510(k) K152764 1 fields · synced May 18, 2026