FDA.reportPublic FDA data

XVS C L-Headset IPD-68 Clear Display

Primary DI
17290113781488
Brand
XVS C L-Headset IPD-68 Clear Display
Company
AUGMEDICS LTD
Model
AHMD682CLT
Published
2025-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
SBFOrthopedic Augmented Reality

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SBFOrthopedic Augmented RealityNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250255000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250255000xvision Spine systemAugmedics, Ltd.2025-03-13SBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290113781488PackageGS11In Commercial Distribution
07290113781474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729011378148817290113781488
07290113781474072901137814747290113781474

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose stereotactic surgery systemAn electrically-powered 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
17290113780979XVS MARKERS WITH XLINK KITASP000472021-08-05
07290113781696X2 HeadsetX20010012025-11-19
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630345729316NextAR TSA PlatformMedacta International SASBF2026-04-13
07630345725912NextAR Spine PlatformMedacta International SASBF2026-01-20
07630542722332NextAR Hip PlatformMedacta International SASBF2026-01-14
07630542759130NextAR™ SpineMedacta International SASBF2025-11-14
07630542759147NextAR™ SpineMedacta International SASBF2025-11-14
07630542720390NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720406NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720413NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720420NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720437NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720444NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542720451NextAR Spine PlatformMedacta International SASBF2025-09-19
07630542765346NextAR (TM) Shoulder PlatformMedacta International SASBF2025-09-17
07630542765353NextAR (TM) Shoulder PlatformMedacta International SASBF2025-09-17
07630542765360NextAR (TM) Shoulder PlatformMedacta International SASBF2025-09-17
07630542765421NextAR (TM) Shoulder PlatformMedacta International SASBF2025-09-17
07630542765438NextAR (TM) Shoulder PlatformMedacta International SASBF2025-09-17
04056481146672Mixed Reality Spine NavigationBrainlab SESBF2025-07-31
00810180350013ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDSBF2025-07-29
04056481143985Mixed Reality Spine NavigationBrainlab SESBF2025-05-31
07630542735448NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735455NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735462NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735479NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735486NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735493NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735509NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735516NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735523NextAR Spine PlatformMedacta International SASBF2024-12-03
07630542735530NextAR Spine PlatformMedacta International SASBF2024-12-03