Identity
- Trade Name
- Ennovate® EUDAMEDENNOVATE FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system rod FDA UDI
- Device Name
- ENNOVATE implant, sterile EUDAMEDENNOVATE MIS STRAIGHT ROD 5.5X120MM FDA UDI
- Model / Reference
- SY912TS EUDAMEDFDA UDI
- Description
- ENNOVATE MIS STRAIGHT ROD 5.5X120MM FDA UDI
Identifiers
- Catalog Number
- SY912TS FDA UDI
- Primary DI / UDI-DI
- 04046964990472 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000012962P EUDAMED
- FDA Product Code
- NKB FDA UDI
- EMDN Code
- P09070304 SPINE FIXATION SYSTEM CONNECTORS EUDAMED
- GMDN Term
- Bone-screw internal spinal fixation system rod FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
Sutures
Yes
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
Ennovate® by Aesculap AG — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 40392390000012962P | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED 243afb16-6e9f-4541-a5ce-bbbc2602f092 61 fields · synced Jun 18, 2026
- FDA UDI f4e8f978-ef38-46f2-88be-2c05f941aa59 37 fields · synced May 30, 2026