Keystone ALIF System

FDA UDI

Class II (US FDA UDI)

by Evolution Spine, Llc

Identity

Trade Name: Keystone ALIF System FDA UDI
Generic Name: Polymeric spinal interbody fusion cage FDA UDI
Device Name: 28x36x13 mm 8 Deg FDA UDI
Model / Reference: AM0813 FDA UDI
Description: 28x36x13 mm 8 Deg FDA UDI

Identifiers

Catalog Number: AM0813 FDA UDI
Primary DI / UDI-DI: 00195860006283 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Polymeric 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

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Angle — 8 degree FDA UDI
Height — 13 Millimeter FDA UDI
Depth — 36 Millimeter FDA UDI
Width — 28 Millimeter FDA UDI

Category: Polymeric spinal interbody fusion cage

Keystone ALIF System by Evolution Spine, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymeric spinal interbody fusion cage.

L-Box® — Innovasis, Inc. · Class II
CoRoent — Nuvasive, Inc. · Class II
Novel Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
S-LIFT® — SPINEFRONTIER, INC. · Class II
Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
TAURUS PEEK Cage System — Medyssey Co., Ltd. · Class II
Cross-Fuse® II PEEK IBF System — Rti Surgical, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II

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: Evolution Spine, Llc

Sources (1)

FDA UDI c5654e56-e607-4954-a32f-e73f6eb49165 36 fields · synced Jun 7, 2026