Identity
- Trade Name
- Ennovate® EUDAMEDENNOVATE C FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system hook FDA UDI
- Device Name
- ENNOVATE C lamina hook EUDAMEDENNOVATE C LAMINA HOOK THIN LEFT FDA UDI
- Model / Reference
- SQ050TS EUDAMEDFDA UDI
- Description
- ENNOVATE C LAMINA HOOK THIN LEFT FDA UDI
Identifiers
- Catalog Number
- SQ050TS FDA UDI
- Primary DI / UDI-DI
- 04046955178520 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000022922N EUDAMED
- Direct Marketing DI
- 04046955178520 EUDAMED
- FDA Product Code
- NKG FDA UDI
- EMDN Code
- P09070301 CERVICAL FIXATION SYSTEMS EUDAMED
- GMDN Term
- Bone-screw internal spinal fixation system hook FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3075 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cervical spine immobilization system, single-use
Ennovate® by Aesculap AG — Class III — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Cervical spine immobilization system, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40392390000022922N | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED c66b9315-ab90-4229-a570-35b18361e43d 61 fields · synced Jul 11, 2026
- FDA UDI 8814b9dc-06a3-4afa-a84a-9b152ffa1df0 35 fields · synced May 30, 2026