FDA.reportPublic FDA data

FixxSure®

Primary DI
M711LS4530
Brand
FixxSure®
Company
INNO Holdings, Inc.
Model
LS-453
Device description
SST, Radel
Published
2022-03-31
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
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M711LS4530PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant driverA hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
801-261-2236info@innovasis.com

Regulatory Flags#

DUNS number
141620464
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M711BTA2020Vector™ Pedicle Screw SystemBTA-2022026-06-05
M711LS7490Vector™ Pedicle Screw SystemLS-7492026-06-05
M711511410070Endeavor™ Stand-Alone Cervical51-1410072026-05-31
M711511410120Endeavor™ Stand-Alone Cervical51-1410122026-05-31
M711511411070Endeavor™ Stand-Alone Cervical51-1411072026-05-31
M711511411120Endeavor™ Stand-Alone Cervical51-1411122026-05-31
M711511412070Endeavor™ Stand-Alone Cervical51-1412072026-05-31
M711511412120Endeavor™ Stand-Alone Cervical51-1412122026-05-31
M711511606070Endeavor™ Stand-Alone Cervical51-1606072026-05-31
M711511607070Endeavor™ Stand-Alone Cervical51-1607072026-05-31
M711511607120Endeavor™ Stand-Alone Cervical51-1607122026-05-31
M711511608070Endeavor™ Stand-Alone Cervical51-1608072026-05-31
M711511608120Endeavor™ Stand-Alone Cervical51-1608122026-05-31
M711511609070Endeavor™ Stand-Alone Cervical51-1609072026-05-31
M711511609120Endeavor™ Stand-Alone Cervical51-1609122026-05-31
M711511610070Endeavor™ Stand-Alone Cervical51-1610072026-05-31
M711511610120Endeavor™ Stand-Alone Cervical51-1610122026-05-31
M711511611070Endeavor™ Stand-Alone Cervical51-1611072026-05-31
M711511611120Endeavor™ Stand-Alone Cervical51-1611122026-05-31
M711511612070Endeavor™ Stand-Alone Cervical51-1612072026-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M719GL2290TiLockGenesys Orthopedics Systems LLCMNI2026-07-14
M719GL2290TiLockGenesys Orthopedics Systems LLCMNH2026-07-14
04047844129418DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129418DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129425DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129425DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129432DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129432DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129449DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129449DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129456DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129456DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129463DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129463DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129470DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129470DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129487DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129487DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129494DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129494DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129500DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129500DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129517DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129517DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129524DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129524DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129531DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129531DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129548DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129548DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13