FDA.reportPublic FDA data

Superion Indirect Decompression System

Primary DI
00088466000529
Brand
Superion Indirect Decompression System
Company
VERTIFLEX, INC.
Model
8mm
Catalog number
101-9808
Device description
Superion Indirect Decompression System, 8mm
Published
2019-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
00088466000529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00088466000529000884660005290884660005290088466000529

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
Width8Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
005235436
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00884662000307Superion Interspinous Spacer16mm100-98162017-02-10
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

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
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
00884662000130Superion InserterVERTIFLEX, INC.NQO2017-08-16