FDA.reportPublic FDA data

Schanz screw 4mmx150mm, 10 pack

Primary DI
07290115752939
Brand
Schanz screw 4mmx150mm, 10 pack
Company
MAZOR ROBOTICS LTD
Model
KIT1538-02
Published
2023-03-31
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
07290115752939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290115752939072901157529397290115752939

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic surgery system probe, reusableA slender, rod-like, hand-held manual surgical instrument intended for use 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 with that of a targeted tissue of interest in a patient so the tissue area is precisely identified with respect to diagnostic images stored in the stereotactic surgery system. It is made of metal. 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
07290109184968Surgeon's screen Sterile Sleeve,10 packKIT0741-032021-01-27
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

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