FDA.reportPublic FDA data

Mazor X Instrument Set Case 2

Primary DI
07290115751871
Brand
Mazor X Instrument Set Case 2
Company
MAZOR ROBOTICS LTD
Model
MAS2307-03S
Published
2022-03-01
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
07290115751871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290115751871072901157518717290115751871

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing clinical instruments (typically endoscopes or surgical instruments) for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It is typically in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. 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
07290109184074BranchMAS2637-01MAS2637-01S2020-04-22
07290109184142360° BridgeMAS2313-01MAS2313-01S2020-04-22
07290109184159Bridge AdaptorMAS2382-01MAS2382-01S2020-04-22
07290109184166Bridge LockMAS2383-01MAS2383-01S2020-04-22
07290109184173MIST BridgeMAS2438-01MAS2438-01S2020-04-22
07290109184180Radiolucent MIS ClampMAS2480-01MAS2480-01S2020-04-22
07290109184197Tall ClampMAS2608-01MAS2608-01S2020-04-22
07290109184203Short ClampMAS2609-01MAS2609-01S2020-04-22
07290109184210Standard BridgeMAS2638-01MAS2638-01S2020-04-22
07290109184227Short BranchMAS2643-01MAS2643-01S2020-04-22
07290109183886StarDriver KitMAS2536-04KIT0893-032020-01-14
072901091838934.75 Arm Guide Screw KitMSA2654-03KIT0893-032020-01-14
072901091839094.75 Arm Guide KITMAS2655-04KIT0895-032020-01-14
072901091839165.5/6.0 Arm Guide Screw KitMAS2656-03KIT0896-032020-01-14
072901091839235.5/6.0 Arm Guide KitMAS2658-04KIT0897-032020-01-14
07290109183930Snapshot Tracker Kit MAS2659-03KIT0898-032020-01-14
07290109183947Robotic Frame Connection KitMAS2662-03KIT0899-032020-01-14
07290109183619StarDriver KitMAS2536-03KIT0893-022019-10-03
072901091836264.75 Arm Guide Screw KitMAS2654-02KIT0894-022019-10-03
072901091836334.75 Arm Guide KitMAS2655-03KIT0895-022019-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00199150054398StealthStation S8MEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150067626KIT 9736691 SPINE REFERENCINGMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150074396CLAMP 9736433 SPINE STRAIGHT TALLMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150074402CLAMP 9736465 SPINE STRAIGHT MEDIUMMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150074419CLAMP 9736434 SPINE STRAIGHT SHORTMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150074426CLAMP 9736467 SPINE DOUBLE MEDIUMMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00763000989927AXIS HYBRID REF FRAME 9736511MEDTRONIC NAVIGATION, INC.OLO2026-08-07
00763000989941AXIS EM SEGMENT TRACKER DRIVER 9736513MEDTRONIC NAVIGATION, INC.OLO2026-08-07
00850059977637TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977644TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977651TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977668TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
00850059977675TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-08-07
75401622522125Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-08-07
00198953246405Xeleris V Processing and Review SystemG E MEDICAL SYSTEMS ISRAEL LTD.LLZ2026-08-03
00840493425559RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425566RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425573RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425580RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425597RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425603RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425610RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425627RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425634RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425641RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425658RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425665RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425672RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03
00840493425689RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-03