FDA.reportPublic FDA data

FortiFix

Primary DI
00814216026927
Brand
FortiFix
Company
NANOVIS SPINE, LLC
Model
NV-880-1204
Catalog number
NV-880-1204
Device description
Nano FortiFix (C) Screw module
Published
2021-07-28
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
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203452000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203452000Nano FortiFix® SystemNanovis, LLC2020-12-22NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814216026927PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814216026927008142160269278142160269270814216026927

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a stabilization device (e.g., rod, plate) to bone; it 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 available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

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
Manufacturing date on label
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
00840493422596RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422602RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422619RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422626RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422633RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422640RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422657RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422664RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422671RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422688RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422695RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422701RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422718RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422725RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422732RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422749RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422756RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422763RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422770RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422787RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422794RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422800RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422817RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422824RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422831RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422848RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422855RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422862RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422879RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422886RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05