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EVOL®ha-C Cervical Interbody System

FDA UDI

Class II (US FDA UDI)

by Cutting Edge Spine

Identity

Trade Name
EVOL®ha-C Cervical Interbody System FDA UDI
Generic Name
Orthopaedic cement restrictor sizer FDA UDI
Device Name
EVOL®ha-C Cervical TRIAL 12WX12D 7° 5H-6H FDA UDI
Model / Reference
CES-374 FDA UDI
Description
EVOL®ha-C Cervical TRIAL 12WX12D 7° 5H-6H FDA UDI

Identifiers

Catalog Number
CES-374 FDA UDI
Primary DI / UDI-DI
00841193121024 FDA UDI
510(k) Number
K180674 FDA UDI
FDA Product Code
ODP FDA UDI
GMDN Term
Orthopaedic cement restrictor sizer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 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

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 400 Millimeter FDA UDI

Category: Orthopaedic cement restrictor sizer

EVOL®ha-C Cervical Interbody System by Cutting Edge Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic cement restrictor sizer.

Cleared under the same submission

K180674 also covers:

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 18c321cf-6fde-488d-bc98-6fdd733e035a 38 fields · synced May 30, 2026