E3D-A Interbody System

FDA UDI

Class II (US FDA UDI)

by Evolution Spine, Llc

Identity

Trade Name: E3D-A Interbody System FDA UDI
Generic Name: Metallic spinal interbody fusion cage FDA UDI
Device Name: STATIC ALIF 36 X 26mm 8deg 15mm (P 11mm) FDA UDI
Model / Reference: 111G-M0815 FDA UDI
Description: STATIC ALIF 36 X 26mm 8deg 15mm (P 11mm) FDA UDI

Identifiers

Catalog Number: 111G-M0815 FDA UDI
Primary DI / UDI-DI: 10195860021122 FDA UDI
510(k) Number: K223146 FDA UDI
K232432 FDA UDI
K240368 FDA UDI
FDA Product Code: MAX FDA UDI
PHM FDA UDI
GMDN Term: Metallic spinal interbody fusion cage 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 36 Millimeter FDA UDI
Depth — 26 Millimeter FDA UDI
Angle — 8 degree FDA UDI
Height — 15 Millimeter FDA UDI

Category: Metallic spinal interbody fusion cage

E3D-A Interbody System by Evolution Spine, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metallic spinal interbody fusion cage.

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Peridot-PT Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
CoRoent — Nuvasive, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
MectaLIF 3D — Medacta International · Class II
PILLAR TL — Orthofix US LLC · Class II
Solar™ Interbody Fusion System — Degen Medical · Class II
Peridot-TD Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II

Cleared under the same submission

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

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Manufacturer

Manufacturer: Evolution Spine, Llc

Sources (1)

FDA UDI 014e7660-9ca6-4fd1-b9e9-f61cf1c44465 37 fields · synced May 31, 2026