FDA.reportPublic FDA data

Superion Interspinous Spacer

Primary DI
00884662000307
Brand
Superion Interspinous Spacer
Company
VERTIFLEX, INC.
Model
16mm
Catalog number
100-9816
Device description
Superion Interspinous Spacer, 16mm
Published
2017-02-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NQOProsthesis, Spinous Process Spacer/Plate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQOProsthesis, Spinous Process Spacer/PlateUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884662000307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884662000307008846620003078846620003070884662000307

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar interspinous decompression spacer, sterileA sterile device intended to be implanted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures, typically to treat a patient with symptomatic degenerative lumbar spinal stenosis (DLSS). It is typically designed as a small spacer, either a single-piece or assembly, made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and/or synthetic polymer [e.g., hydrogel, polyetheretherketone (PEEK)]. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width16Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
005235436
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884662000246Superion Interspinous Spacer10mm100-98102017-02-10
00884662000222Superion Interspinous Spacer8mm100-98082017-02-10
00884662000260Superion Interspinous Spacer12mm100-98122017-02-10
00884662000284Superion Interspinous Spacer14mm100-98142017-02-10
00884662000123Superion DriverN/A100-91082017-08-16
00884662000130Superion InserterN/A100-91102017-08-16
00884662000147Superion Grasping ForcepsN/A100-91122017-08-16
00884662000154Superion Interspinous GaugeN/A100-91152017-08-16
00884662000178Superion Interspinous ReamerN/A100-91172017-08-16
00884662000185Superion Sterilization TrayN/A100-91192017-08-16
00884662000192Superion RetractorN/A100-91262017-08-16
00884662000208Superion MalletN/A100-91272017-08-16
00884662000321Superion Dilator 1, BluntN/A100-91352017-08-16
00884662000338Superion Dilator 2N/A100-91362017-08-16
00884662000345Superion CannulaN/A100-91372017-08-16
00884662000352Superion HandleN/A100-91392017-08-16
00884662000369Superion Dilator 1N/A100-91462017-08-16
00088466000529Superion Indirect Decompression System8mm101-98082019-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701521300347DIAM™ Spinal Stabilization SystemCOMPANION SPINE FRANCENQO2025-12-19
03701521300354DIAM™ Spinal Stabilization SystemCOMPANION SPINE FRANCENQO2025-12-19
03701521300361DIAM™ Spinal Stabilization SystemCOMPANION SPINE FRANCENQO2025-12-19
03701521300378DIAM™ Spinal Stabilization SystemCOMPANION SPINE FRANCENQO2025-12-19
03701521300385DIAM™ Spinal Stabilization SystemCOMPANION SPINE FRANCENQO2025-12-19
04260636678998coflex instrument loaner setParadigm Spine GmbHNQO2023-03-31
00884662000529Superion™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2020-09-28
00088466000529Superion Indirect Decompression SystemVERTIFLEX, INC.NQO2019-02-04
00884662000536Superion™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2019-02-04
00884662000543Superion™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2019-02-04
00884662000550Superion™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2019-02-04
00884662000567Superion™BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2019-02-04
04260148897825coflex crimping pliers, longParadigm Spine GmbHNQO2018-10-23
04260148897849coflex dual pliersParadigm Spine GmbHNQO2018-10-10
04260148897856coflex MalletParadigm Spine GmbHNQO2018-08-02
04260148897863coflex mallet capParadigm Spine GmbHNQO2018-08-02
04260148897740coflex trial with guide and x-ray marker, 8mmParadigm Spine GmbHNQO2018-06-28
04260148897757coflex trial with guide and x-ray marker, 10mmParadigm Spine GmbHNQO2018-06-28
04260148897764coflex trial with guide and x-ray marker, 12mmParadigm Spine GmbHNQO2018-06-28
04260148897771coflex trial with guide and x-ray marker, 14mmParadigm Spine GmbHNQO2018-06-28
04260148897788coflex trial with guide and x-ray marker, 16mmParadigm Spine GmbHNQO2018-06-28
04260148897795coflex trial slider with wingsParadigm Spine GmbHNQO2018-06-28
04260148897801coflex trial capParadigm Spine GmbHNQO2018-06-28
04260148897832coflex wing loosenerParadigm Spine GmbHNQO2018-06-28
04260148898594coflex freehand crimping pliersParadigm Spine GmbHNQO2018-06-28
04260148898600coflex extractor pliersParadigm Spine GmbHNQO2018-06-28
04260148898358coflex single-use instrumentsParadigm Spine GmbHNQO2018-06-14
00884662000574Superion™ SUIBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2018-04-05
00884662000611Vertiflex™ VIPBOSTON SCIENTIFIC NEUROMODULATION CORPORATIONNQO2018-04-05
00884662000123Superion DriverVERTIFLEX, INC.NQO2017-08-16