FDA.reportPublic FDA data

Neuro & Craniofacial Fixation System

Primary DI
M711LS4240
Brand
Neuro & Craniofacial Fixation System
Company
INNO Holdings, Inc.
Model
LS-424
Catalog number
LS-424
Device description
SST
Published
2018-08-13
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
GXLScrewdriver, Skullplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXLScrewdriver, SkullplateNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M711LS4240PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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
DM exempt
true
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
07610733850365OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850372OPERACEPB SWISS TOOLS AGGXL2024-09-24
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07610733850556OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850563OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850600OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850617OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850624OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850655OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850693OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850709OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850716OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733851966OPERACEPB SWISS TOOLS AGGXL2024-09-24
06903195298570Disposable Screwdriver BladeKontour(Xi'An) Medical Technology Co.,Ltd.GXL2024-03-22
06903195298587Disposable Screwdriver BladeKontour(Xi'An) Medical Technology Co.,Ltd.GXL2024-03-22
04056481145606HEX SCREWDRIVER T-HANDLE (2.5 MM)Brainlab SEGXL2023-10-19
00888233048361SEEG LONG BOLT DRIVERBIOMET MICROFIXATION, INCGXL2023-06-07
00888233048378SEEG SHORT BOLT DRIVERBIOMET MICROFIXATION, INCGXL2023-06-07
00856482008467KLS E-Coupling AdapterPRO-DEX, INC.GXL2023-05-23
04056481144708Skull Reference Screwdriver HandleBrainlab SEGXL2023-05-05
04056481144715Skull Reference Screwdriver BladeBrainlab SEGXL2023-05-05
G28435301ScrewdriverNeurovention LLCGXL2022-06-21
00856482008252Pro-Dex CMF Surgical Driver (AXS™ NEURO DRIVER)PRO-DEX, INC.GXL2022-04-01
00856482008269MatrixPRO II Handpiece LoanerPRO-DEX, INC.GXL2022-04-01
00856482008283Battery Pack, Single Use, PDCMF, TadiranPRO-DEX, INC.GXL2022-04-01
00860540000225MatrixPRO Driver LoanerPRO-DEX, INC.GXL2022-04-01
00856482008122BATTERY PACK, KLS-SD-2000, SINGLEPRO-DEX, INC.GXL2022-03-29
00862377000140BATTERY PACK, KLS-SD-1000, SINGLEPRO-DEX, INC.GXL2022-03-29
00856482008016KLS E-Coupling AdapterPRO-DEX, INC.GXL2022-03-29
00856482008115KLS MaxDriver 2 PRO-DEX, INC.GXL2022-03-29