← Back to catalogue
icotec Cervical Cage, Lordotic, ↕ 5 mm ↔ 13 mm
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 12-40-0513
by icotec ag
Identity
- Trade Name
- icotec Cervical Cage, Lordotic, ↕ 5 mm ↔ 13 mm EUDAMEDicotec Cervical Cage, Lordotic, 5 mm x 13 mm FDA UDI
- Generic Name
- Polymeric spinal interbody fusion cage FDA UDI
- Device Name
- Cervical Cage EUDAMEDicotec Cervical Cage, Lordotic, 5 mm x 13 mm FDA UDI
- Model / Reference
- 12-40-0513 EUDAMEDFDA UDI
- Description
- icotec Cervical Cage, Lordotic, 5 mm x 13 mm FDA UDI
Identifiers
- Catalog Number
- 12-40-0513 FDA UDI
- Primary DI / UDI-DI
- 07640140430553 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640140430553 EUDAMED
- FDA Product Code
- ODP FDA UDI
- EMDN Code
- P09070101 SPINAL CAGES EUDAMED
- GMDN Term
- Polymeric 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
icotec Cervical Cage, Lordotic, ↕ 5 mm ↔ 13 mm by icotec AG — 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-07640140430553 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- icotec ag
- EUDAMED SRN
- CH-MF-000026833
- Authorised Representative
- icotec Medical GmbH DE-AR-000016837
Sources (2)
- EUDAMED a405e15c-3221-4287-bbbd-c845c6ab171e 61 fields · synced Jul 16, 2026
- FDA UDI 8b8ffd1d-e946-4e21-aafd-50bff968568b 35 fields · synced May 24, 2026