FDA.reportPublic FDA data

Schanz Screw 4X120mm

Primary DI
07290109184012
Brand
Schanz Screw 4X120mm
Company
MAZOR ROBOTICS LTD
Model
MAS2866-01
Catalog number
KIT2866-01
Published
2021-03-14
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
07290109184012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109184012072901091840127290109184012

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
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
00854810007229iCRco Clarity ViewerIcRco, Inc.LLZ2026-07-22
17540262200102Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-07-22
00840466901035PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901042PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901059PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901066PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901073PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901080PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901097PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901103PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901110PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901127PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901141PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901158PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901165PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901172PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901479PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901486PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901493PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901509PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901516PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901523PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901530PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901547PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901554PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901561PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901578PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901585PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901592PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901608PrimusSPINAL ELEMENTS, INC.OLO2026-07-21