FDA.reportPublic FDA data

SUPSTANCE Small

Primary DI
03700449613447
Brand
SUPSTANCE Small
Company
H.P.I.
Model
100112832
Catalog number
100112832
Device description
The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR) system intended to replace a vertebral body. It is designed for use in the cervical and in the thoracolumbar spine (C3 - L5) to replace a collapsed, damaged or unstable vertebral body during tumor or trauma management and to replace a partially removed vertebral body in the management of degenerative disorders.
Published
2015-11-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
03700449613447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700449613447037004496134473700449613447

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle8degree
Length32Millimeter
Width12Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
268469389
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700449613300SUPSTANCE Small1001125181001125182015-11-12
03700449613324SUPSTANCE Small1001125201001125202015-11-12
03700449613348SUPSTANCE Small1001125221001125222015-11-12
03700449613362SUPSTANCE Small1001125241001125242015-11-12
03700449613386SUPSTANCE Small1001125261001125262015-11-12
03700449613409SUPSTANCE Small1001125281001125282015-11-12
03700449613423SUPSTANCE Small1001125301001125302015-11-12
03700449613461SUPSTANCE Small1001128341001128342015-11-12
03700449613485SUPSTANCE Small1001128361001128362015-11-12
03700449613508SUPSTANCE Small1001128381001128382015-11-12
03700449613522SUPSTANCE Small1001128401001128402015-11-12
03700449613546SUPSTANCE Small1001128421001128422015-11-12
03700449613560SUPSTANCE Small1001128441001128442015-11-12
03700449613584SUPSTANCE Small1001128461001128462015-11-12
03700449613607SUPSTANCE Small1001128481001128482015-11-12
03700449613621SUPSTANCE Small1001128501001128502015-11-12
03700449613645SUPSTANCE Small1001145181001145182015-11-12
03700449613669SUPSTANCE Small1001145201001145202015-11-12
03700449613683SUPSTANCE Small1001145221001145222015-11-12
03700449613706SUPSTANCE Small1001145241001145242015-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840283403460LumiVy™VY SPINE LLCMQP2026-06-05
00763000857844T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-01
00763000857943T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-01
00763000857998T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-01
07640172551103KONG-TL VBR System, Expansion Handleicotec AGMQP2020-06-19
07640172551110KONG-TL VBR System, Locking Rodicotec AGMQP2020-06-19
08033726407923DSCSINTEA PLUSTEK SRLMQP2015-10-16
08033726404250DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726404267DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407664DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407671DSCSINTEA PLUSTEK SRLMQP2015-10-09
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