FDA.reportPublic FDA data

XVS L-Headset IPD-60 Clear Display

Primary DI
07290113780804
Brand
XVS L-Headset IPD-60 Clear Display
Company
AUGMEDICS LTD
Model
AHMD602WLT
Published
2021-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument
SBFOrthopedic Augmented Reality

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2
SBFOrthopedic Augmented RealityNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190929000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190929000xvision Spine system (XVS)Augmedics, Ltd.2019-12-20SBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290113780801PackageGS11In Commercial Distribution
07290113780804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729011378080117290113780801
07290113780804072901137808047290113780804

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

Regulatory Flags#

DUNS number
600325755
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290113781139C-arm adaptor enclosureAMCH077022026-03-11
17290113780924Perc Pin 150mm 5 units PackageAMCH070152021-08-05
17290113780931Perc Pin 125mm 5 units PackageAMCH070122021-08-05
17290113780948Perc Pin 100mm 5 units PackageAMCH070102021-08-05
17290113780979XVS MARKERS WITH XLINK 10 SETS PACKASP000462021-08-05
07290113780101XVS STERILE COMPONENTS KITASP000142020-03-16
07290113780606XVS Headset IPD-68 Clear DisplayAHMD681WLT2020-08-06
07290113780989XVS STERILE COMPONENTS KITASP000502021-09-05
07290113781061Augmedics WS-Cart assemblyACC004012024-03-18
07290113780996Swivel 3-4 mm universal tool adapter Leg upAMCRMU032022-12-13
07290113781009Standard xvision tray, instruments includedAMCH000402022-12-13
07290113781016Standard perc pin tray, instruments includedAMCH000412022-12-13
07290113780859Perc Pin TrayAMCH071002021-08-05
07290113780866Perc Insertion CapAMCH073202021-08-05
07290113780873Perc Slap HammerAMCH073702021-08-05
07290113780880Perc Mallet 250 gr. AMCH077002021-08-05
07290113780897Perc Schanz Screw Adaptor ShortAMCH075002021-08-05
07290113780903Schanz Screw Adaptor LongAMCH075502021-08-05
07290113780910Perc Pin AdaptorAMCH072002021-08-05
07290113780958XVISION Instrument TrayASP000442021-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810180351720360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-07-09
10705034647302CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647319CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647326CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647333CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647340CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647357CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647364CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647371CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647388CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647395CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647418CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647425CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647432CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647449CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647456CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647470CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647487CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647494CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647500CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647517CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647524CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647531CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647548CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647555CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647562CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647579CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647586CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647593CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647609CROSSNAV CONDUITMedos International SàrlOLO2026-07-09