Identity
- Trade Name
- EVOL®SI Joint Fusion System FDA UDI
- Generic Name
- Orthopaedic implant/instrument assembling device FDA UDI
- Device Name
- EVOL®SI, Screwdriver (T40 Cannulated) FDA UDI
- Model / Reference
- CES-323 FDA UDI
- Description
- EVOL®SI, Screwdriver (T40 Cannulated) FDA UDI
Identifiers
- Catalog Number
- CES-323 FDA UDI
- Primary DI / UDI-DI
- 00841193122540 FDA UDI
- GMDN Term
- Orthopaedic implant/instrument assembling device FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implant/instrument assembling device
EVOL®SI Joint Fusion System by Cutting Edge Spine — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic implant/instrument assembling device.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Cutting Edge Spine
Sources (1)
- FDA UDI e6a3f14a-dcae-4cbd-9e56-d114e5144d52 36 fields · synced May 31, 2026