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GSO GS1 Spacer

Primary DI
M9935023070
Brand
GSO GS1 Spacer
Company
UNIFIED SPINE, LLC
Model
502307
Device description
Spacer
Published
2016-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQPSpinal Vertebral Body Replacement Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9935023070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Interspinous spinal fixation implantAn implantable device intended to be attached to two adjacent vertebral spinous processes to provide immobilization and stabilization of spinal segments as an adjunct to bony fusion in the treatment of spinal conditions (e.g., degenerative disc disease, spondylolisthesis, tumour, trauma). It is intended to be used on the thoracic, lumbar or sacral spine during a minimally-invasive procedure. It is made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and may incorporate bone graft pockets. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height7Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
118413370
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M9935042050GSO GS1 Spinal System5042052018-09-21
M9935042180GSO GS1 Spinal System5042182018-09-21
M9935042190GSO GS1 Spinal System5042192018-09-21
M9935071650GSO PCT Spinal System5071652018-09-21
M9935071760GSO PCT Spinal System5071762018-09-21
M9935071770GSO PCT Spinal System5071772018-09-21
M9935091200GSO ACP1 Anterior Cervical Plate System5091202016-09-14
M9935091220GSO ACP1 Anterior Cervical Plate System5091222016-09-14
M9935091240GSO ACP1 Anterior Cervical Plate System5091242016-09-14
M9935091260GSO ACP1 Anterior Cervical Plate System5091262016-09-14
M9935091280GSO ACP1 Anterior Cervical Plate System5091282016-09-14
M9935091300GSO ACP1 Anterior Cervical Plate System5091302016-09-15
M9935091320GSO ACP1 Anterior Cervical Plate System5091322016-09-14
M9935092340GSO ACP1 Anterior Cervical Plate System5092342016-09-15
M9935092370GSO ACP1 Anterior Cervical Plate System5092372016-09-15
M9935092400GSO ACP1 Anterior Cervical Plate System5092402016-09-15
M9935092430GSO ACP1 Anterior Cervical Plate System5092432016-09-15
M9935092460GSO ACP1 Anterior Cervical Plate System5092462016-09-15
M9935092490GSO ACP1 Anterior Cervical Plate System5092492016-09-15
M9935092520GSO ACP1 Anterior Cervical Plate System5092522016-09-15

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Primary DI, Brand, Company table
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08033726407701DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407718DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407725DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407732DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407749DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407756DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407763DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407770DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407787DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407794DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407800DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407817DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407824DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407831DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407848DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407855DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407862DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407879DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407886DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407893DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407909DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407916DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726408029DSCSINTEA PLUSTEK SRLMQP2015-10-09