Identity
- Trade Name
- Ennovate® EUDAMEDENNOVATE FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system connector FDA UDI
- Device Name
- ENNOVATE implant, sterile EUDAMEDENNOVATE TRANSCONNECTOR 30MM STERILE FDA UDI
- Model / Reference
- SX942TS EUDAMEDFDA UDI
- Description
- ENNOVATE TRANSCONNECTOR 30MM STERILE FDA UDI
Identifiers
- Catalog Number
- SX942TS FDA UDI
- Primary DI / UDI-DI
- 04046964995637 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 connector 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED 852f40e8-9749-4a12-9fe5-71e628719034 61 fields · synced Jul 16, 2026
- FDA UDI be126800-2631-4193-9bcb-99e770a1ca76 37 fields · synced May 30, 2026