Identity
- Trade Name
- ARTISAN™ SPACE MAINTENANCE SYSTEM FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, metal FDA UDI
- Device Name
- MESH 7000040 TITANIUM FDA UDI
- Model / Reference
- 7000040 FDA UDI
- Description
- MESH 7000040 TITANIUM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994802538 FDA UDI
- 510(k) Number
- K100779 FDA UDI
- FDA Product Code
- JEY FDA UDIDZE FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, metal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4760 FDA UDI872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
MR Conditional FDA UDI
Category: Extra-gynaecological surgical mesh, metal
Artisan™ Space Maintenance System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K100779 also covers:
- ARTISAN™ SPACE MAINTENANCE SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- ARTISAN™ SPACE MAINTENANCE SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- ARTISAN™ SPACE MAINTENANCE SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- ARTISAN™ SPACE MAINTENANCE SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- ARTISAN™ SPACE MAINTENANCE SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- ARTISAN™ SPACE MAINTENANCE SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
- ARTISAN™ SPACE MAINTENANCE SYSTEM — MEDTRONIC SOFAMOR DANEK, INC.
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
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI a62a4727-6c75-495c-b962-f373dd75405f 35 fields · synced Jun 1, 2026