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EVOL® -SI Joint Fusion System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K190025

by Cutting Edge Spine, LLC

Identity

Trade Name
EVOL®SI Joint Fusion System FDA UDI
Generic Name
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated FDA UDI
Device Name
EVOL®SI, 11.5mm Washer FDA UDI
Model / Reference
5006-WT FDA UDI
Description
EVOL®SI, 11.5mm Washer FDA UDI

Identifiers

Catalog Number
5006-WT FDA UDI
Primary DI / UDI-DI
00841193122991 FDA UDI
510(k) Number
K190025 FDA 510(k)FDA UDI
FDA Product Code
OUR FDA 510(k)FDA UDI
GMDN Term
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3040 FDA 510(k)
Regulation Number
888.3040 FDA 510(k)FDA UDI
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

EVOL® -SI Joint Fusion System by Cutting Edge Spine, LLC — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cutting Edge Spine, LLC

Sources (2)

  • FDA 510(k) K190025 24 fields · synced Jun 18, 2026
  • FDA UDI 596e15d8-b237-4603-8761-e57b68404440 37 fields · synced May 27, 2026