icotec Cervical Cage, Inserter Sleeve with Depth Limiter, -
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
by icotec ag
Identity
- Trade Name
- icotec Cervical Cage, Inserter Sleeve with Depth Limiter, - EUDAMEDicotec Cervical Cage, Inserter Sleeve with Depth Limiter FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- icotec Cervical Cage, Inserter Sleeve with Depth Limiter FDA UDI
- Model / Reference
- Inserter Sleeve EUDAMED41-13-3 EUDAMEDFDA UDI
- Description
- icotec Cervical Cage, Inserter Sleeve with Depth Limiter FDA UDI
Identifiers
- Catalog Number
- 41-13-3 FDA UDI
- Primary DI / UDI-DI
- 07640164842363 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017255iCSI00013R EUDAMED
- Direct Marketing DI
- 07640164842363 EUDAMED
- FDA Product Code
- MAX FDA UDIODP FDA UDI
- EMDN Code
- L1109 NEUROSURGERY AND SPINAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Classification
- Device Class
- Class 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Device sterilization/disinfection container, reusable
icotec Cervical Cage, Inserter Sleeve with Depth Limiter, - by icotec AG — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192897 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 764017255iCSI00013R | Class IIa | Active |
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Manufacturer
- Manufacturer
- icotec ag
- EUDAMED SRN
- CH-MF-000026833
- Authorised Representative
- icotec Medical GmbH DE-AR-000016837
Sources (3)
- EUDAMED f1b68a8c-e6d3-4c89-b2db-7b621e99ff86 61 fields · synced Aug 2, 2026
- FDA UDI eab2572d-e57e-49e0-b1e4-82276d7ec607 35 fields · synced May 30, 2026
- FDA 510(k) K192897 1 fields · synced May 18, 2026