FOUNDATION System

FDA UDI

Class II (US FDA UDI)

by Corelink Llc

Identity

Trade Name: FOUNDATION System FDA UDI
Generic Name: Polymeric spinal interbody fusion cage FDA UDI
Device Name: FOUNDATION LATERAL CAGE - 18MM X 50MM X 16MM, 8 DEGREE FDA UDI
Model / Reference: 830850-16 FDA UDI
Description: FOUNDATION LATERAL CAGE - 18MM X 50MM X 16MM, 8 DEGREE FDA UDI

Identifiers

Catalog Number: 830850-16 FDA UDI
Primary DI / UDI-DI: M72583085016 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

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: Width — 18 Millimeter FDA UDI
Height — 16 Millimeter FDA UDI
Length — 50 Millimeter FDA UDI
Angle — 8 degree FDA UDI

Category: Polymeric spinal interbody fusion cage

The FOUNDATION System is a non-surgical, porous intervertebral disc fusion device designed for partial or total removal of an intervertebral disc in the treatment of degenerative disc disease (DDD). It provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur, typically using bone graft. The device consists of a hollow, threaded, and/or fenestrated cylindrical or geometrical structure made of non-bioabsorbable synthetic polymer, including polyetheretherketone (PEEK), which is fixated with implantation screws and devices.

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: Corelink Llc

Sources (1)

FDA UDI 0f42af04-be0d-4a16-a443-078ca25144e9 36 fields · synced Jun 20, 2026