FDA.reportPublic FDA data

Renaissance System

Primary DI
17290109180267
Brand
Renaissance System
Company
MAZOR ROBOTICS LTD
Model
TPL0038-03
Published
2016-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290109180267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729010918026717290109180267

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97246187100info@mazorrobotics.com

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
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
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
07290115752199Mazor X Navigation CameraTPL0063-702025-01-29
07290115752502Surgical System Sleeve,10 PackKIT0953-04 2025-11-20
07290115753462Mazor X Scan & Plan Disposable KitKIT0571-112025-07-11
07290115753479Mazor X Spine Disposable KitKIT0574-132025-07-11
07290115753455Mazor X Guidewire Instruments SetKIT0854-052025-05-07
07290115751307StarDriver KitKIT0893-062025-04-27
072901157513144.75 Arm Guide Screw KitKIT0894-062025-04-27
072901157513214.75 Arm Guide KitKIT0895-062025-04-27
072901157513385.5/6.0 Arm Guide Screw KitKIT0896-062025-04-27
072901157513455.5/6.0 Arm Guide KitKIT0897-062025-04-27
07290115751352Snapshot Tracker KitKIT0898-062025-04-27
07290115751369Robotic Frame Connection KitKIT0899-062025-04-27
07290115751895Mazor X SystemTPL0059-102025-04-27
07290118271925Universal ScrewdriverMAS1650-06S2025-01-30
07290115752755Mazor X Navigation CameraTPL0063-072025-01-22
07290115751215Mazor X Bone Mount CaseMAS2712-02KIT2712-022024-12-30
07290115752229Mazor X Surgical InstrumentsKIT0762-042024-12-30
07290115752236Bridge AdaptorMAS2382-04KIT2382-032024-12-30
07290115752243Bridge LockMAS2383-04KIT2383-032024-12-30
07290115752250Schanz ConnectorMAS2851-03KIT2851-032024-12-30