EndoLIF® DoubleWedge-Cage 16 12°
EUDAMEDFDA UDIClass IIb (EU MDR)
by Joimax GmbH
Identity
- Trade Name
- EndoLIF® DoubleWedge-Cage 16 12° EUDAMEDEndoLIF® FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- EndoLIF® DoubleWedge-Cage 16 12° EUDAMEDFDA UDI
- Model / Reference
- ELDW64321612 EUDAMEDFDA UDI
- Description
- EndoLIF® DoubleWedge-Cage 16 12° FDA UDI
Identifiers
- Catalog Number
- ELDW64321612 FDA UDI
- Primary DI / UDI-DI
- 04250337117261 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337117261 EUDAMED
- FDA Product Code
- MAX FDA UDI
- EMDN Code
- P09070101 SPINAL CAGES EUDAMED
- GMDN Term
- Metallic spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
For the EndoLIF DoubleWedge-Cage 16 12° device, this comprehensive medical device directory provides an overview of its latest features, human tissues it is designed for, sterilization process, and more. It also offers answers to frequently asked questions about this medical device.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04250337117261 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Joimax GmbH
- EUDAMED SRN
- DE-MF-000009201
Sources (2)
- EUDAMED e3d5d1f4-1817-42bc-805d-bc109220d166 61 fields · synced Jul 20, 2026
- FDA UDI c0bb991c-f2ee-4746-8577-c8c8d557b0cc 36 fields · synced May 30, 2026