SUPSTANCE Large

FDA UDI

Class II (US FDA UDI)

by Hpi, Inc.

Identity

Trade Name: SUPSTANCE Large FDA UDI
Generic Name: Polymeric spinal interbody fusion cage FDA UDI
Device Name: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended to replace a vertebral body. It is designed for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body during tumor or trauma (i.e, fracture) management procédures. FDA UDI
Model / Reference: 100128375 FDA UDI
Description: The SUPSTANCE Large VBR system is a PEEK Optima vertebral body replacement (VBR) system intended to replace a vertebral body. It is designed for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body during tumor or trauma (i.e, fracture) management procédures. FDA UDI

Identifiers

Catalog Number: 100128375 FDA UDI
Primary DI / UDI-DI: 03700449614758 FDA UDI
FDA Product Code: MQP FDA UDI
GMDN Term: Polymeric spinal interbody fusion cage FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 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

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

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Angle — 5 degree FDA UDI
Length — 37.5 Millimeter FDA UDI
Outer Diameter — 28 Millimeter FDA UDI

Category: Polymeric spinal interbody fusion cage

SUPSTANCE Large by Hpi, Inc. — 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

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Manufacturer

Manufacturer: Hpi, Inc.

Sources (1)

FDA UDI 0b1b9497-c405-44cc-9e54-b2935b2f2370 35 fields · synced Jun 8, 2026