FDA.reportPublic FDA data

Mazor X Spine Disposable Kit

Primary DI
07290115750881
Brand
Mazor X Spine Disposable Kit
Company
MAZOR ROBOTICS LTD
Model
KIT0574-08
Published
2021-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
K200935000
K203005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200935000Mazor XMazor Robotics , Ltd.2020-05-08OLO
K203005000Mazor XMazor Robotics , Ltd.2020-10-27OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290115750881PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290115750881072901157508817290115750881

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Regulatory Flags#

DUNS number
532681590
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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00190376729374Invictus Spinal Fixation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376729435Invictus Spinal Fixation SystemALPHATEC SPINE, INC.OLO2026-10-29
04056481147648Quip Link Instrument Tracking Array For 3 Marker Spheres MBrainlab SEOLO2026-10-29
04056481147655Quip Link Instrument Tracking Array For 3 Marker Spheres MLBrainlab SEOLO2026-10-29
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04056481147679Quip Link Instrument Tracking Array For 3 Marker Spheres L1Brainlab SEOLO2026-10-29
04056481147686Quip Link Instrument Tracking Array For 3 Marker Spheres L2Brainlab SEOLO2026-10-29
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04056481147723Quip Instrument Adapter Clamp Softgrip Size XLBrainlab SEOLO2026-10-29
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04056481147754Quip Instrument Adapter Extension 50 mmBrainlab SEOLO2026-10-29
04056481147761Quip Instrument Adapter 45° AngledBrainlab SEOLO2026-10-29
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04250337118985J-Needle Navi WL 120, trocar, 11 GJoimax GmbHOLO2026-10-28
04719878712002OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.LLZ2026-10-28
00887868578922ROSA® KneeOrthosoft IncOLO2026-10-27
00887868578939ROSA Partial Knee SoftwareOrthosoft IncOLO2026-10-27
00887868581090ROSA® RoboticsOrthosoft IncOLO2026-10-27
00887868581106ROSA® RoboticsOrthosoft IncOLO2026-10-27
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