Superion™

FDA UDI

Class III (US FDA UDI)

by Boston Scientific Neuromodulation

Identity

Trade Name: Superion™ FDA UDI
Generic Name: Lumbar decompression interspinous spacer FDA UDI
Device Name: Indirect Decompression System FDA UDI
Model / Reference: 101-9808 FDA UDI
Description: Indirect Decompression System FDA UDI

Identifiers

Catalog Number: 101-9808 FDA UDI
Primary DI / UDI-DI: 00884662000529 FDA UDI
PMA Number: P140004 FDA UDI
FDA Product Code: NQO FDA UDI
GMDN Term: Lumbar decompression interspinous spacer FDA UDI

Classification

Device Class: Class III 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

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Width — 8 Millimeter FDA UDI

Category: Lumbar decompression interspinous spacer

Superion™ by Boston Scientific Neuromodulation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lumbar decompression interspinous spacer.

Affix — Nuvasive, Inc. · Class II
Affix — Nuvasive, Inc. · Class II
Affix — Nuvasive, Inc. · Class II
X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC. · Class III
InterBRIDGE — Ldr Spine USA · Class II
X-STOP® Interspinous Spacer — MEDTRONIC SOFAMOR DANEK, INC. · Class III
InterBRIDGE — Ldr Spine USA · Class II
Affix — Nuvasive, Inc. · Class II

Cleared under the same submission

P140004 also covers:

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 III	Pending data

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Manufacturer

Manufacturer: Boston Scientific Neuromodulation

Sources (1)

FDA UDI 7bc29e20-8019-4380-b665-2d8ddfaeca19 36 fields · synced May 31, 2026