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: Bone graft packing block FDA UDI
Device Name: EVOL®ha-C Cervical Bone Packing Block FDA UDI
Model / Reference: CES-472 FDA UDI
Description: EVOL®ha-C Cervical Bone Packing Block FDA UDI

Identifiers

Catalog Number: CES-472 FDA UDI
Primary DI / UDI-DI: 00841193121246 FDA UDI
510(k) Number: K180674 FDA UDI
FDA Product Code: ODP FDA UDI
GMDN Term: Bone graft packing block 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 50 Millimeter FDA UDI

Category: Bone graft packing block

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 Bone graft packing block.

TRYPTIK CC INSTRUMENTATION — Spineart · Class II
Vu aPod™ - L — SeaSpine Orthopedics Corporation · Class I
SI-LUTION Sacroiliac Joint Fusion System — Curiteva, LLC · Class II
Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
ZOLL-DENTAL — Zoll-Dental · Class I
SANTORINI™ Corpectomy Cage System — K2M, INC. · Class I
Savant Lumbar Interbody Fusion System — Curiteva, LLC · Class II
PERLA TL — Spineart · Class I

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	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Cutting Edge Spine

Sources (1)

FDA UDI 5918a8bd-380a-4610-8c33-966973e26cc6 38 fields · synced May 30, 2026

EVOL®ha-C Cervical Interbody System

Identity

Identifiers

Classification

Clinical & Handling

Dimensions & Sizes

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)