icotec Pedicle System Nut Screw, Ti
EUDAMEDFDA UDIClass IIb (EU MDR)
by icotec ag
Identity
- Trade Name
- icotec Pedicle System Nut Screw, Ti EUDAMEDicotec Pedicle System, Nut Screw, Ti FDA UDI
- Generic Name
- Implantable bone washer FDA UDI
- Device Name
- Pedicle System Nut Screw (Ti) EUDAMEDicotec Pedicle System, Nut Screw, Ti FDA UDI
- Model / Reference
- 16-57-41000 EUDAMEDFDA UDI
- Description
- icotec Pedicle System, Nut Screw, Ti FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640140431994 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017255PSINUTSTi0014F EUDAMED
- FDA Product Code
- NKB FDA UDIPML FDA UDI
- EMDN Code
- P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
- GMDN Term
- Implantable bone washer FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3027 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
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
Yes
Manufacturing Date
No
Category: Spinal bone screw, non-bioabsorbable
icotec Pedicle System Nut Screw, Ti by icotec AG — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal bone screw, non-bioabsorbable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764017255PSINUTSTi0014F | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- icotec ag
- EUDAMED SRN
- CH-MF-000026833
- Authorised Representative
- icotec Medical GmbH DE-AR-000016837
Sources (2)
- EUDAMED 9f2a5ead-4f24-4ed9-a2eb-425748495014 61 fields · synced Jul 27, 2026
- FDA UDI 53e0f379-1b6f-4259-9285-76aaf6c958d2 34 fields · synced May 29, 2026