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EVOL®SI Joint Fusion System

FDA UDI

Class II (US FDA UDI)

by Cutting Edge Spine

Identity

Trade Name
EVOL®SI Joint Fusion System FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Device Name
EVOL®SI Stackable Steinmann Pin, 3.2 Blunt End FDA UDI
Model / Reference
CES-318 FDA UDI
Description
EVOL®SI Stackable Steinmann Pin, 3.2 Blunt End FDA UDI

Identifiers

Primary DI / UDI-DI
00841193124995 FDA UDI
FDA Product Code
OUR FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
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

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic prosthesis implantation positioning instrument, single-use

EVOL®SI Joint Fusion System by Cutting Edge Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cutting Edge Spine

Sources (1)

  • FDA UDI 8af9dd9d-b8d2-4e80-a986-3ba6f5b95520 34 fields · synced May 30, 2026