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EndoLIF® O-Cage 14
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref ELO643514
by Joimax GmbH
Identity
- Trade Name
- EndoLIF® O-Cage 14 EUDAMEDEndoLIF® FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- EndoLIF® O-Cage 14 EUDAMEDFDA UDI
- Model / Reference
- ELO643514 EUDAMEDFDA UDI
- Description
- EndoLIF® O-Cage 14 FDA UDI
Identifiers
- Catalog Number
- ELO643514 FDA UDI
- Primary DI / UDI-DI
- 04250337104124 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337104124 EUDAMED
- 510(k) Number
- K151143 FDA UDI
- 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® O-Cage 14 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-04250337104124 | 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 3b9560c5-60ac-440c-b40d-daa923f9c578 61 fields · synced Jul 10, 2026
- FDA UDI a76be319-c108-4a53-8adb-f5bb1a7063b6 37 fields · synced May 30, 2026