icotec Cervical Cage Anatomic 8 x 18 mm

FDA UDI

Class II (US FDA UDI)

by Icotec

Identity

Trade Name: icotec Cervical Cage Anatomic 8 x 18 mm FDA UDI
Generic Name: Polymeric spinal interbody fusion cage FDA UDI
Device Name: icotec Cervical Cage Anatomic 8 x 18 mm FDA UDI
Model / Reference: 13-41-0818 FDA UDI
Description: icotec Cervical Cage Anatomic 8 x 18 mm FDA UDI

Identifiers

Catalog Number: 13-41-0818 FDA UDI
Primary DI / UDI-DI: 07640164848020 FDA UDI
FDA Product Code: MAX FDA UDI
ODP 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Polymeric spinal interbody fusion cage

The icotec Cervical Cage Anatomic 8 x 18 mm cervical spine fusion device is a non-surgical treatment option for degenerative disc disease (DDD), providing mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. Made of polymeric material, it features fixation screws and devices associated with implantation.

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

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Manufacturer

Manufacturer: Icotec

Sources (1)

FDA UDI 50e6d198-acaf-465a-ae0a-ac546b79e4d9 35 fields · synced Jul 19, 2026