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 42-45MM STERILE FDA UDI
- Model / Reference
- SX948TS EUDAMEDFDA UDI
- Description
- ENNOVATE TRANSCONNECTOR 42-45MM STERILE FDA UDI
Identifiers
- Catalog Number
- SX948TS FDA UDI
- Primary DI / UDI-DI
- 04046964995699 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
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: Bone-screw internal spinal fixation system connector
Ennovate® by Aesculap AG — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system connector.
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- APEX Spine System — SPINECRAFT LLC · Class II
- ReLine — Nuvasive, Inc. · Class II
- APEX Spine System — SPINECRAFT LLC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 3622b580-9bbb-496f-9690-6c5462be1c19 61 fields · synced Jun 19, 2026
- FDA UDI f32db8f4-b54d-41ff-985a-5c319942efcf 37 fields · synced May 30, 2026