FDA.reportPublic FDA data

Nanovis Cervical FortiCore

Primary DI
00814216026354
Brand
Nanovis Cervical FortiCore
Company
NANOVIS SPINE, LLC
Model
11291-1606
Catalog number
11291-1606
Device description
Dome Cerv Trial, No Stop 14x16x06 6°
Published
2020-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00814216026354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814216026354008142160263548142160263540814216026354

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
Depth0.551Inch
Height0.236Inch
Width0.63Inch

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00814216028259Adaptix™ PEEK Interbody System with Nanotechnology74332407743324072024-10-30
00814216028266Adaptix™ PEEK Interbody System with Nanotechnology74332408743324082024-10-30
00814216028273Adaptix™ PEEK Interbody System with Nanotechnology74332409743324092024-10-30
00814216028280Adaptix™ PEEK Interbody System with Nanotechnology74332410743324102024-10-30
00814216028297Adaptix™ PEEK Interbody System with Nanotechnology74332411743324112024-10-30
00814216028303Adaptix™ PEEK Interbody System with Nanotechnology74332412743324122024-10-30
00814216028310Adaptix™ PEEK Interbody System with Nanotechnology74332413743324132024-10-30
00814216028327Adaptix™ PEEK Interbody System with Nanotechnology74332414743324142024-10-30
00814216028334Adaptix™ PEEK Interbody System with Nanotechnology74332415743324152024-10-30
00814216028341Adaptix™ PEEK Interbody System with Nanotechnology74332416743324162024-10-30
00814216028358Adaptix™ PEEK Interbody System with Nanotechnology74332806743328062024-10-30
00814216028365Adaptix™ PEEK Interbody System with Nanotechnology74332807743328072024-10-30
00814216028372Adaptix™ PEEK Interbody System with Nanotechnology74332808743328082024-10-30
00814216028389Adaptix™ PEEK Interbody System with Nanotechnology74332809743328092024-10-30
00814216028396Adaptix™ PEEK Interbody System with Nanotechnology74332810743328102024-10-30
00814216028402Adaptix™ PEEK Interbody System with Nanotechnology74332811743328112024-10-30
00814216028419Adaptix™ PEEK Interbody System with Nanotechnology74332812743328122024-10-30
00814216028426Adaptix™ PEEK Interbody System with Nanotechnology74332813743328132024-10-30
00814216028433Adaptix™ PEEK Interbody System with Nanotechnology74332814743328142024-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840283404245ClariVy™VY SPINE LLCODP2026-03-19
00840283404252ClariVy™VY SPINE LLCODP2026-03-19
00840283404269ClariVy™VY SPINE LLCODP2026-03-19
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00840283404283ClariVy™VY SPINE LLCODP2026-03-19
00840493416687LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
00840493416694LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
00840493416700LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
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00841193127538EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
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00841193127620EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127637EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127644EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127651EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
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10195860030452E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030506E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
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