Cervical Interbody Fusion System

FDA UDI

Class I (US FDA UDI)

by Evolution Spine, Llc

Identity

Trade Name: Cervical Interbody Fusion System FDA UDI
Generic Name: Spinal implant trial FDA UDI
Device Name: 14x16x 10mm, 11mm , 10 Deg Trial FDA UDI
Model / Reference: AC-TL-10-01011 FDA UDI
Description: 14x16x 10mm, 11mm , 10 Deg Trial FDA UDI

Identifiers

Catalog Number: AC-TL-10-01011 FDA UDI
Primary DI / UDI-DI: 00195860006078 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Spinal implant trial FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Width — 14 Millimeter FDA UDI
Angle — 10 degree FDA UDI
Depth — 16 Millimeter FDA UDI

Category: Spinal implant trial

Cervical Interbody Fusion System by Evolution Spine, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Evolution Spine, Llc

Sources (1)

FDA UDI 9bba485e-cbe0-4604-96e0-028bbc1ef26f 36 fields · synced Jun 7, 2026