FDA.reportPublic FDA data

FortiBridge

Primary DI
10814216022681
Brand
FortiBridge
Company
NANOVIS SPINE, LLC
Model
10703-4018
Catalog number
10703-4018
Device description
FortiBridge Variable Screw 4mm x 18mm
Published
2019-03-04
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
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143706000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143706000FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC2015-04-10KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814216022681PrimaryGS10
00814216022677Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081421602268110814216022681
00814216022677008142160226778142160226770814216022677

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Millimeter
Outer Diameter4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-907-6266nanovisquality@nanovistechnology.com

Regulatory Flags#

DUNS number
079898044
Device count
2
DM exempt
true
Lot or batch
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
08809986491145CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491152CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491169CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491176CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491183CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491190CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491206CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491213CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491220CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491237CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491244CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491251CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491268CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491275CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491282CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491299CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491305CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491312CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491329CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491336CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491343CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491350CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491367CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491374CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491381CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491398CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
00840311248360Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248421Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248438Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248445Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03