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EndoLIF® O-Cage 13 Short
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref ELO643013
by Joimax GmbH
Identity
- Trade Name
- EndoLIF® O-Cage 13 Short EUDAMEDEndoLIF® FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- EndoLIF® O-Cage 13 Short EUDAMEDFDA UDI
- Model / Reference
- ELO643013 EUDAMEDFDA UDI
- Description
- EndoLIF® O-Cage 13 Short FDA UDI
Identifiers
- Catalog Number
- ELO643013 FDA UDI
- Primary DI / UDI-DI
- 04250337105619 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337105619 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 13 Short 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-04250337105619 | 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 b67d68c0-d93d-4e2c-a5cc-cf7bf71dfa5c 61 fields · synced Jul 20, 2026
- FDA UDI 84621327-ed1e-4211-877a-e31dab0e24a6 37 fields · synced May 30, 2026