FDA.reportPublic FDA data

Swivel 6-7.5mm universal tool adapter Leg Down

Primary DI
07290113780668
Brand
Swivel 6-7.5mm universal tool adapter Leg Down
Company
AUGMEDICS LTD
Model
AMCRMD06
Published
2020-09-15
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
07290113780668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290113780668072901137806687290113780668

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
1
Serial number
true
Manufacturing date on label
true
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
00199150067633Stealth AXiS Advanced Spine Referencing KitMEDTRONIC NAVIGATION, INC.OLO2026-09-06
00763000994501Stealth AXiS Spine Referencing Kit SSMEDTRONIC NAVIGATION, INC.OLO2026-09-06
00763000994525Stealth AXiS Advanced Spine Referencing Kit SSMEDTRONIC NAVIGATION, INC.OLO2026-09-06
00763000994549Stealth AXiS EM Emitter Arm Bed Kit SSMEDTRONIC NAVIGATION, INC.OLO2026-09-06
00763000994563Stealth AXiS EM Spine Retractors Kit SSMEDTRONIC NAVIGATION, INC.OLO2026-09-06
00885556925171REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925188REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00889024673403NavitrackER®Orthosoft IncOLO2026-06-26
00885556919743Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919767Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
04056481146429Automatic RegsitrationBrainlab SEOLO2026-02-20
00810180350051ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-11-17
00810180350099ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-11-17
00810180350112ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-11-17
04056481146702Curve NavigationBrainlab SEOLO2025-10-13
04056481146054Patient Reference Rod-Clamp Spine & TraumaBrainlab SEOLO2025-09-19
04056481146672Mixed Reality Spine NavigationBrainlab SESBF2025-07-31
00810180350013ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDSBF2025-07-29
006283415213837D Surgical Universal Array (5)7D Surgical ULCOLO2025-07-28
006283415213907D Surgical Universal Array (6)7D Surgical ULCOLO2025-07-28
04056481145439PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE SBrainlab SEOLO2025-06-17
04056481145446PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE LBrainlab SEOLO2025-06-17
04056481146320Alignment Software SpineBrainlab SEOLO2025-06-16
00850042604311Paradigm Drill Guide TrocarProprio, Inc.OLO2025-06-09
04056481143985Mixed Reality Spine NavigationBrainlab SESBF2025-05-31
00810180350266ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350433ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350525ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350556ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350563ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23