icotec Anterior Cervical Plate System Drill, AO coupling Ø 3mm for 15 mm screw
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
by icotec ag
Identity
- Trade Name
- icotec Anterior Cervical Plate System Drill, AO coupling Ø 3mm for 15 mm screw EUDAMEDicotec Anterior Cervical Plate System, Drill, AO coupling, Ø3 mm for 15 mm screw FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- icotec Anterior Cervical Plate System, Drill, AO coupling, Ø3 mm for 15 mm screw FDA UDI
- Model / Reference
- Drill EUDAMED39-3-15 EUDAMEDFDA UDI
- Description
- icotec Anterior Cervical Plate System, Drill, AO coupling, Ø3 mm for 15 mm screw FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640140434476 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017255iCPI00072W EUDAMED
- Direct Marketing DI
- 07640140434476 EUDAMED
- FDA Product Code
- KWQ FDA UDI
- EMDN Code
- L1109 NEUROSURGERY AND SPINAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
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 Anterior Cervical Plate System Drill, AO coupling Ø 3mm for 15 mm screw by icotec AG — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA…
Similar devices
Also classified as Device sterilization/disinfection container, reusable.
- SM - LIPO PANTY CHEVILLES COUPE TAILLE NOIR AVEC TROUS RECOUVERTS SUR MESURE — MEDICAL Z · Class I
- APTUS — Medartis Inc. · Class I
- APTUS — Medartis Inc. · Class II
- INSTRUMENTS TRAYS WITHOUT LID, 200x100x25MM — DAUD JEE MFG. CO · Class I
- Breastform Cover Right Size 03 (478/ 482) — Trulife · Class I
- NCB® Periprosthetic Plate System — Zimmer, Inc. · Class I
- NTOC cassette — NTOC medische techniek B.V · Class I
- MIRABOR-CA (12 BURS)- — Hager Worldwide, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233215 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K201587 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 764017255iCPI00072W | Class IIa | Active |
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 (3)
- EUDAMED b377394b-dfd4-4508-aa13-7954aab0d6c5 61 fields · synced Oct 6, 2026
- FDA UDI c6a0477d-902a-45d1-bd15-827928a43838 34 fields · synced May 30, 2026
- FDA 510(k) K233215 1 fields · synced May 18, 2026