FDA.reportPublic FDA data

N/A

Primary DI
10705034536156
Brand
N/A
Company
Medos International Sàrl
Model
302011012
Catalog number
302011012
Device description
UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION RING diameter 12
Published
2021-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201661000
K212756000
K223108000
K233254000
K233256000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201661000Symphony Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL2020-09-16OLO
K212756000Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL2022-05-05OLO
K223108000TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)Medos International SARL2023-01-19OLO
K233254000TELIGEN System Navigation Ready InstrumentsDePuy Synthes2024-06-14OLO
K233256000Robotic Integration InstrumentsDePuy Synthes2024-06-17OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034536156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503453615610705034536156

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical navigation device tracking system spatial register connectorA non-sterile component of a surgical navigation device tracking system (e.g., optical device tracking system, electromagnetic device tracking system) intended to connect the system’s spatial register [localizer/tracker/calibrator (e.g., infrared light reflector)] to a navigated surgical instrument (e.g., a stereotactic surgery system probe, dental drill), and/or to a navigation fiducial marker, during computer assisted surgery (CAS); it may be affixed via dedicated screws. It is typically made of metallic or polymer materials and may be in the shape of a handle to facilitate handling the instrument during a procedure. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705032266NA2423332423332026-07-22
10886705001309RIGIDFIX BIOCRYL2108162108162015-09-01
10705034647302CROSSNAV CONDUIT3010-21-9963010219962026-07-09
10705034647319CROSSNAV CONDUIT3010-21-9993010219992026-07-09
10705034647326CROSSNAV CONDUIT3010-21-3323010213322026-07-09
10705034647333CROSSNAV CONDUIT3010-21-3313010213312026-07-09
10705034647340CROSSNAV CONDUIT3010-21-2103010212102026-07-09
10705034647357CROSSNAV CONDUIT3010-21-2113010212112026-07-09
10705034647364CROSSNAV CONDUIT3010-21-2123010212122026-07-09
10705034647371CROSSNAV CONDUIT3010-21-2133010212132026-07-09
10705034647388CROSSNAV CONDUIT3010-21-2143010212142026-07-09
10705034647395CROSSNAV CONDUIT3010-21-2153010212152026-07-09
10705034647418CROSSNAV CONDUIT3010-21-2083010212082026-07-09
10705034647425CROSSNAV CONDUIT3010-21-2093010212092026-07-09
10705034647432CROSSNAV CONDUIT3010-21-3203010213202026-07-09
10705034647449CROSSNAV CONDUIT3010-21-3153010213152026-07-09
10705034647456CROSSNAV CONDUIT3010-21-9983010219982026-07-09
10705034647463N/A3010-21-3403010213402026-07-09
10705034647470CROSSNAV CONDUIT3010-21-3013010213012026-07-09
10705034647487CROSSNAV CONDUIT3010-21-3033010213032026-07-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00199150074396CLAMP 9736433 SPINE STRAIGHT TALLMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150074402CLAMP 9736465 SPINE STRAIGHT MEDIUMMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150074419CLAMP 9736434 SPINE STRAIGHT SHORTMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00199150074426CLAMP 9736467 SPINE DOUBLE MEDIUMMEDTRONIC NAVIGATION, INC.OLO2026-08-07
00763000989927AXIS HYBRID REF FRAME 9736511MEDTRONIC NAVIGATION, INC.OLO2026-08-07
00763000989941AXIS EM SEGMENT TRACKER DRIVER 9736513MEDTRONIC NAVIGATION, INC.OLO2026-08-07
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