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Trial Implant Cages 13
EUDAMEDFDA UDIClass I (EU MDR)
Ref ELO640013T
by Joimax GmbH
Identity
- Trade Name
- Trial Implant Cages 13 EUDAMEDtrial implant FDA UDI
- Generic Name
- Internal spinal fixation procedure kit, reusable FDA UDI
- Device Name
- Trial Implant Cages 13 EUDAMEDFDA UDITrial Implant Cages 08 EUDAMED
- Model / Reference
- ELO640013T EUDAMEDFDA UDI
- Description
- Trial Implant Cages 13 FDA UDI
Identifiers
- Catalog Number
- ELO640013T FDA UDI
- Primary DI / UDI-DI
- 04250337111184 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337111184 EUDAMED42503371INCATRIEC EUDAMED
- Direct Marketing DI
- 04250337111184 EUDAMED
- 510(k) Number
- K151143 FDA UDI
- FDA Product Code
- MAX FDA UDI
- EMDN Code
- L1199 NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Internal spinal fixation procedure kit, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIa 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
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMEDEUDAMED
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Trial Implant Cages 13 by Joimax GmbH — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04250337111184 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04250337111184 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Joimax GmbH
- EUDAMED SRN
- DE-MF-000009201
Sources (3)
- EUDAMED 26fab14d-db09-480b-8ff1-f2239b790261 61 fields · synced Jul 14, 2026
- FDA UDI 8c8cc646-03d8-4717-9159-76b2e0bc3316 37 fields · synced May 30, 2026
- EUDAMED 20506e7c-1d5a-4b88-92ee-562301478e2a 61 fields · synced Jul 14, 2026