FDA.reportPublic FDA data

TRIALTIS

Primary DI
10705034589343
Brand
TRIALTIS
Company
Medos International Sàrl
Model
5161-00-2040
Catalog number
5161002040
Device description
TRIALTIS Spine System Tap,Navigated Awl Tip 4.0mm 3-5cm ± 1%
Published
2024-02-01
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
NKBThoracolumbosacral pedicle screw system
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231527000
K233255000
K241893000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231527000TriALTIS Navigation Enabled InstrumentsMedos International Sàrl2023-09-29OLO
K233255000CROSSNAV Navigation Enabled InstrumentsDePuy Synthes2024-06-17OLO
K241893000CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL2024-09-16OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034589343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503458934310705034589343

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000914097Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-24
00841732169272PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169289PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169296PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169302PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169319PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
10888857598164Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598256Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598263Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598270Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598287Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598294Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598300Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598317Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598324Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598331Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598348Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598355Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598362Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598379Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598386Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598393Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24