Identity
- Trade Name
- ModuLeX™ Shank Mount FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- SPINE REFERENCING DEVICES EUDAMEDMODULEX SHANK MOUNT RIGHT 9736438 FDA UDI
- Model / Reference
- 9736438 EUDAMEDFDA UDI
- Description
- MODULEX SHANK MOUNT RIGHT 9736438 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00199150074488 EUDAMED00763000713126 FDA UDI
- Basic UDI-DI
- 0763000B00009198G EUDAMED
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12130480 STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Multi-purpose stereotactic surgery system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 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
Yes
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
No
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: Multi-purpose stereotactic surgery system
ModuLeX™ Shank Mount by Medtronic Navigation, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Medtronic Navigation, Inc.
Sources (2)
- FDA UDI 2c4838d4-ef6e-4568-894e-47c9d8f374ae 34 fields · synced Jul 9, 2026
- EUDAMED 699c6e89-e747-41b6-a127-df8296ddd7d2 61 fields · synced Jul 9, 2026