FDA.reportPublic FDA data

Nano FortiCore®

Primary DI
00814216024626
Brand
Nano FortiCore®
Company
NANOVIS SPINE, LLC
Model
11703-1406N
Catalog number
11703-1406N
Device description
Nano FortiCore® Flat Cervical 14 X 12 X 6, 6°
Published
2020-03-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814216024626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814216024626008142160246268142160246260814216024626

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
Depth12Millimeter
Height6Millimeter
Width14Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8779076266nanovisquality@nanovistechnology.com

Regulatory Flags#

DUNS number
079898044
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
00810017914548Saber-C Body (PT), 14x17x6 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914555Saber-C Body (PT), 14x17x8 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914562Saber-C Body (PT), 14x17x7 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914579Saber-C Body (PT), 14x17x9 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914586Saber-C Body (PT), 14x17x10 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00810017914647Saber-C Plate, 14x17x10 12 deg.ELEVATION SPINE, INC.ODP2026-07-23
00843511102579Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-07-23
00843511102135Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102142Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102159Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102166Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102173Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102180Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102197Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102203Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102210Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102227Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102234Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102241Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102258Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102265Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102272Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102289Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102296Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102302Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102319Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102326Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102333Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102340Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102357Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22