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EndoLIF® DoubleWedge-Cage 10 Short 12°
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref ELDW64271012
by Joimax GmbH
Identity
- Trade Name
- EndoLIF® DoubleWedge-Cage 10 Short 12° EUDAMEDEndoLIF® FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- EndoLIF® DoubleWedge-Cage 10 Short 12° EUDAMEDFDA UDI
- Model / Reference
- ELDW64271012 EUDAMEDFDA UDI
- Description
- EndoLIF® DoubleWedge-Cage 10 Short 12° FDA UDI
Identifiers
- Catalog Number
- ELDW64271012 FDA UDI
- Primary DI / UDI-DI
- 04250337117063 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337117063 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
EndoLIF® DoubleWedge-Cage 10 Short 12° by Joimax GmbH — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04250337117063 | 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 675c3572-7848-4a76-8337-b58bfee23bd5 61 fields · synced Jul 23, 2026
- FDA UDI a9bb89d5-531f-437d-b7db-82fe5237e26f 36 fields · synced May 30, 2026