FDA.reportPublic FDA data

FortiCore

Primary DI
00814216023766
Brand
FortiCore
Company
NANOVIS SPINE, LLC
Model
10492-2215
Catalog number
10492-2215
Device description
FortiCore PLIF Trial (15x9.5x22,6°)
Published
2019-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814216023766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814216023766008142160237668142160237660814216023766

GMDN Terms#

Term, Definition table
TermDefinition
Metal-polymer composite 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 a non-bioabsorbable synthetic polymer with a metallic coating 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
Height15Millimeter
Length22Millimeter
Width9.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8779076266nanovisquality@nanovistechnology.com

Regulatory Flags#

DUNS number
079898044
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814216026330FortiCore®11299-000111299-00012020-04-07
00814216026347FortiCore®11299-000211299-00022020-04-07
00814216026354Nanovis Cervical FortiCore®11291-160611291-16062020-04-07
00814216026361FortiCore®11291-160711291-16072020-04-07
00814216026378FortiCore®11291-160811291-16082020-04-07
00814216026385FortiCore®11291-160911291-16092020-04-07
00814216024619Nano FortiCore®11703-1405N11703-1405N2020-03-27
00814216024640Nano FortiCore®11703-1408N11703-1408N2020-03-27
00814216024657Nano FortiCore®11703-1409N11703-1409N2020-03-27
00814216024664Nano FortiCore®11703-1410N11703-1410N2020-03-27
00814216024671Nano FortiCore®11703-1411N11703-1411N2020-03-27
00814216024770Nano FortiCore®11704-1605N11704-1605N2020-03-27
00814216024787Nano FortiCore®11704-1606N11704-1606N2020-03-27
00814216024794Nano FortiCore®11704-1607N11704-1607N2020-03-27
00814216024800Nano FortiCore®11704-1608N11704-1608N2020-03-27
00814216024817Nano FortiCore®11704-1609N11704-1609N2020-03-27
00814216024824Nano FortiCore®11704-1610N11704-1610N2020-03-27
00814216024831Nano FortiCore®11704-1611N11704-1611N2020-03-27
00814216024848Nano FortiCore®11704-1612N11704-1612N2020-03-27
00814216026392Nano FortiCore®11703-1412N11703-1412N2020-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00843511102241Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
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00843511102272Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
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00843511102333Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102340Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102357Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102364Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102371Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102388Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102395Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102401Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102418Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102425Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22