FDA.reportPublic FDA data

Universal Screwdriver

Primary DI
07290115751574
Brand
Universal Screwdriver
Company
MAZOR ROBOTICS LTD
Model
MAS1650-05S
Published
2022-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203005000Mazor XMazor Robotics , Ltd.2020-10-27OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290115751574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290115751574072901157515747290115751574

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic surgery system probe, reusableA long, slender, rod-like device made of metal, used during image guided surgery (e.g., neurosurgical or orthopaedic surgery procedures) to accurately position implantable devices (e.g., shunts), or to correlate the position of its tip to that of a targeted tissue of interest within a patient so that this area of tissue is clearly pinpointed with respect to diagnostic images stored in the stereotactic surgery system. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
532681590
Device count
1
Kit
true
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
07290115751963Surgeon's Screen Sterile Sleeve,10 packKIT0741-052022-12-18
07290115752212Sterile Clear Sleeve,10 packKIT0742-052022-12-18
07290115751284Mazor X Navigation CameraTPL0063-042022-01-06
07290115752786Mazor X Spine Disposable KitKIT0574-102023-03-31
07290115752878Mazor X Scan & Plan Disposable KitKIT0571-082023-03-31
07290115751291Mazor X Navigation CameraTPL0063-052022-04-15
07290115750867Lateral Optional KitKIT0755-052021-10-21
07290115750737Schanz screw 4mmx80, 10 packKIT0729-052021-08-18
07290115750744Head Pin 2.5x60mm,10 packKIT0731-052021-08-18
07290115750751Auxiliary Drill Guide And Auxiliary CannulaKIT0732-052021-08-18
07290115750768Long Drill 3.0x30, 10 packKIT0733-052021-08-18
07290115750775Short Drill 3x30mm,10 packKIT0734-052021-08-18
07290115750782Long drill 4x80mm,10 packKIT0735-052021-08-18
07290115750799Long drill guide and Long CannulaKIT0736-052021-08-18
07290115750805Short Drill Guide and Short CannulaKIT0737-052021-08-18
07290115750812Long drill 3x80mm,10 packKIT0738-052021-08-18
07290115750829Short Drill 3x80mm,10 packKIT0739-052021-08-18
07290115750836Head Pin 2.5x100mm,10 packKIT0758-052021-08-18
07290115750843Surgeon's screen Sterile Sleeve,10 packKIT0741-042021-08-18
07290115750850Sterile Clear Sleeve,10 packKIT0742-042021-08-18

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Primary DI, Brand, Company table
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04719878712002OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.LLZ2026-10-28
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