FDA.reportPublic FDA data

Superion Mallet

Primary DI
00884662000208
Brand
Superion Mallet
Company
VERTIFLEX, INC.
Model
N/A
Catalog number
100-9127
Device description
Superion Mallet
Published
2017-08-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00884662000208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884662000208008846620002088846620002080884662000208

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar interspinous decompression instrument set, reusableA collection of surgical instruments and devices intended to be used for the implantation of an interspinous process decompression (IPD) implant that is inserted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures; this is typically to treat a patient suffering from symptomatic degenerative lumbar spinal stenosis (DLSS). It typically consists of a tray, dedicated dilators, a sizing instrument, a spacer (the implant) insertion instrument, implant holders, and a torque-limiting screwdriver. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
005235436
Device count
1
Sterilization required before use
true

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
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