FDA.reportPublic FDA data

XVS MARKERS WITH XLINK 10 SETS PACK

Primary DI
27290113780976
Brand
XVS MARKERS WITH XLINK 10 SETS PACK
Company
AUGMEDICS LTD
Model
ASP00046
Published
2021-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
K211188000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211188000xvision Spine system (XVS)Augmedics, Ltd.2021-07-19SBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27290113780976PackageGS110In Commercial Distribution
17290113780979PrimaryGS10
07290113780972Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2729011378097627290113780976
1729011378097917290113780979
07290113780972072901137809727290113780972

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
600325755
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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
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00840493426433RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426440RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426457RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426464RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426471RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426488RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426495RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426501RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426518RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426525RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426532RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426549RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426556RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426563RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426570RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426587RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426594RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426600RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426617RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426624RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426631RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
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