FDA.reportPublic FDA data

Rotating Marker Adaptor

Primary DI
07290113780965
Brand
Rotating Marker Adaptor
Company
AUGMEDICS LTD
Model
AMCH00039
Published
2021-08-05
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
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
07290113780965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290113780965072901137809657290113780965

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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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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