FDA.report

Nanovis Cervical FortiCore

Primary DI
00814216026378
Brand
Nanovis Cervical FortiCore
Company
NANOVIS SPINE, LLC
Model
11291-1608
Catalog number
11291-1608
Device description
Dome Cerv Trial, No Stop 14x16x08 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

Related Records

Contact Domains

Product Codes

CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications

CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00814216026378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00814216026378008142160263788142160263780814216026378

GMDN Terms

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

TypeValueUnit
Depth0.551Inch
Height0.315Inch
Width0.63Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

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